Trial Outcomes & Findings for A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (NCT NCT02967692)

Last Updated: 2025-09-18

Results Overview

DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

568 participants

Primary outcome timeframe

Up to 8 weeks (Part 1)

Results posted on

2025-09-18

Participant Flow

Part 1 and 2 were conducted in 18 centers across 12 countries. Part 3 is conducted in 190 centers across 29 countries

The screening phase began once written informed consent was provided and ended after 28 days or when subject received the first dose (Part 1 and 2) or was randomized (Part 3), whichever came first.

Participant milestones

Participant milestones
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Overall Study STARTED	9	27	267	265
Overall Study Treated	9	27	267	264
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	9	27	267	265

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Overall Study Progressive disease	3	15	114	151
Overall Study Subject/guardian decision	1	1	14	22
Overall Study Death	0	1	13	13
Overall Study Protocol deviation	1	0	1	1
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Physician Decision	0	0	22	13
Overall Study Adverse Event	2	9	60	28
Overall Study Study terminated by sponsor	2	1	42	37

Baseline Characteristics

A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 Participants In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=265 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Total n=568 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	18 Participants n=7 Participants	189 Participants n=5 Participants	195 Participants n=4 Participants	409 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	9 Participants n=7 Participants	78 Participants n=5 Participants	70 Participants n=4 Participants	159 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	12 Participants n=7 Participants	119 Participants n=5 Participants	106 Participants n=4 Participants	239 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	148 Participants n=5 Participants	159 Participants n=4 Participants	329 Participants n=21 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	24 Participants n=7 Participants	225 Participants n=5 Participants	227 Participants n=4 Participants	485 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants	14 Participants n=4 Participants	30 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	22 Participants n=5 Participants	19 Participants n=4 Participants	41 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks (Part 1)

Population: Dose-Determining Set (DDS) including all subjects in Part 1 who received at least one dose of study treatment who either 1) met the minimum exposure criterion and had sufficient safety evaluations, or 2) experienced a DLT during the first 8 weeks (56 days) of spartalizumab in combination with dabrafenib and trametinib dosing.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)	1 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days

Population: Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points

Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib Cycle 1 Day 15	1.7 Percentage of positive tumor cells Standard Deviation 13.05	—	—	—
Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib Cycle 3 Day 1	2.7 Percentage of positive tumor cells Standard Deviation 7.63	—	—	—

PRIMARY outcome

Timeframe: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days

Population: Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points

Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=6 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib Cycle 1 Day 15	0.4 Percentage Marker Area Standard Deviation 3.22	—	—	—
Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib Cycle 3 Day 1	1.2 Percentage Marker Area Standard Deviation 2.43	—	—	—

PRIMARY outcome

Timeframe: Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)

Population: All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.

Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=265 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1	16.2 Months Interval 12.7 to 23.9	12.0 Months Interval 10.2 to 15.4	—	—

SECONDARY outcome

Timeframe: Up to death due to any cause, assessed up to approximately 7 years

Population: All participants to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.

Overall survival was defined as the time from date of randomization to date of death due to any cause

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=265 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Overall Survival (OS)	NA Months Interval 12.2 to Not estimable (NA) due to the insufficient number of participants with events	30.7 Months Interval 21.3 to 67.4	61.5 Months Interval 41.6 to Not estimable (NA) due to the insufficient number of participants with events	41.6 Months Interval 30.6 to 56.9

SECONDARY outcome

Timeframe: Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years

Population: For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment. For Part 3: all subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered.

ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=265 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1	100.0 Percentage of participants Interval 66.4 to 100.0	70.4 Percentage of participants Interval 49.8 to 86.2	68.5 Percentage of participants Interval 62.6 to 74.1	64.2 Percentage of participants Interval 58.1 to 69.9

SECONDARY outcome

Timeframe: From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)

Population: For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment for whom best overall response was CR or PR. For Part 3: all subjects to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) for whom best overall response was CR or PR.

DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=19 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=183 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=170 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1	NA Months Interval 8.3 to Not estimable (NA) due to the insufficient number of participants with events	20.0 Months Interval 9.4 to Not estimable (NA) due to the insufficient number of participants with events	NA Months Interval 18.6 to Not estimable (NA) due to the insufficient number of participants with events	20.7 Months Interval 13.0 to Not estimable (NA) due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year

DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=265 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1	100.0 Percentage of participants Interval 66.4 to 100.0	92.6 Percentage of participants Interval 75.7 to 99.1	84.3 Percentage of participants Interval 79.3 to 88.4	86.4 Percentage of participants Interval 81.7 to 90.3

SECONDARY outcome

Timeframe: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)

Population: All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points

The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=175 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=186 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 6 Day 1	1.22 Score on a Scale Standard Deviation 25.050	1.90 Score on a Scale Standard Deviation 21.197	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 14 Day 1	0.65 Score on a Scale Standard Deviation 23.561	-0.89 Score on a Scale Standard Deviation 23.306	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 18 Day 1	-0.46 Score on a Scale Standard Deviation 24.106	-0.10 Score on a Scale Standard Deviation 19.193	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 4 Day 1	0.81 Score on a Scale Standard Deviation 19.300	2.20 Score on a Scale Standard Deviation 24.918	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 8 Day 1	0.00 Score on a Scale Standard Deviation 24.526	0.50 Score on a Scale Standard Deviation 19.608	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 10 Day 1	1.88 Score on a Scale Standard Deviation 23.088	0.27 Score on a Scale Standard Deviation 18.752	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 12 Day 1	0.61 Score on a Scale Standard Deviation 25.906	0.00 Score on a Scale Standard Deviation 24.541	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 16 Day 1	0.82 Score on a Scale Standard Deviation 25.186	1.76 Score on a Scale Standard Deviation 24.142	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 20 Day 1	1.93 Score on a Scale Standard Deviation 21.766	-1.02 Score on a Scale Standard Deviation 23.144	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 22 Day 1	0.95 Score on a Scale Standard Deviation 22.047	2.29 Score on a Scale Standard Deviation 21.947	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 25 Day 1	3.57 Score on a Scale Standard Deviation 23.981	-0.24 Score on a Scale Standard Deviation 25.497	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 28 Day 1	4.50 Score on a Scale Standard Deviation 19.793	1.06 Score on a Scale Standard Deviation 22.513	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 31 Day 1	11.59 Score on a Scale Standard Deviation 24.967	6.73 Score on a Scale Standard Deviation 21.084	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores Cycle 34 Day 1	16.67 Score on a Scale Standard Deviation 47.140	13.89 Score on a Scale Standard Deviation 20.184	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores 30 days post-progression	-11.59 Score on a Scale Standard Deviation 24.967	-7.78 Score on a Scale Standard Deviation 29.274	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores 60 days post-progression	-11.54 Score on a Scale Standard Deviation 16.506	-17.19 Score on a Scale Standard Deviation 24.050	—	—

SECONDARY outcome

Timeframe: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)

The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning. The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=175 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=186 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 16 Day 1	-4.19 Score on a Scale Standard Deviation 20.301	-2.24 Score on a Scale Standard Deviation 13.331	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 18 Day 1	-3.48 Score on a Scale Standard Deviation 18.862	-3.55 Score on a Scale Standard Deviation 13.474	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 25 Day 1	-1.35 Score on a Scale Standard Deviation 16.510	-2.67 Score on a Scale Standard Deviation 13.158	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 28 Day 1	-0.80 Score on a Scale Standard Deviation 13.843	-2.67 Score on a Scale Standard Deviation 15.953	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 31 Day 1	-2.03 Score on a Scale Standard Deviation 10.719	-1.79 Score on a Scale Standard Deviation 9.533	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores 60 days post-progression	-13.85 Score on a Scale Standard Deviation 15.977	-21.25 Score on a Scale Standard Deviation 27.991	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 4 Day 1	-1.52 Score on a Scale Standard Deviation 16.243	-0.70 Score on a Scale Standard Deviation 17.618	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 6 Day 1	-2.38 Score on a Scale Standard Deviation 16.121	-0.60 Score on a Scale Standard Deviation 14.824	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 8 Day 1	-1.29 Score on a Scale Standard Deviation 18.350	-0.59 Score on a Scale Standard Deviation 15.687	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 10 Day 1	-0.18 Score on a Scale Standard Deviation 17.985	-1.11 Score on a Scale Standard Deviation 13.736	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 12 Day 1	-1.39 Score on a Scale Standard Deviation 18.108	-0.85 Score on a Scale Standard Deviation 10.652	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 14 Day 1	-2.42 Score on a Scale Standard Deviation 16.720	-2.61 Score on a Scale Standard Deviation 12.320	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 20 Day 1	-4.07 Score on a Scale Standard Deviation 15.316	-1.73 Score on a Scale Standard Deviation 11.536	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 22 Day 1	-3.21 Score on a Scale Standard Deviation 15.538	-0.85 Score on a Scale Standard Deviation 11.157	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores Cycle 34 Day 1	0.00 Score on a Scale Standard Deviation 0.000	-3.33 Score on a Scale Standard Deviation 5.578	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores 30 days post-progression	-6.67 Score on a Scale Standard Deviation 18.641	-8.67 Score on a Scale Standard Deviation 19.973	—	—

SECONDARY outcome

Timeframe: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)

The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain. The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=175 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=186 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 25 Day 1	-6.25 Score on a Scale Standard Deviation 28.868	-4.76 Score on a Scale Standard Deviation 20.685	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 34 Day 1	-8.33 Score on a Scale Standard Deviation 11.785	-5.56 Score on a Scale Standard Deviation 8.607	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores 30 days post-progression	9.42 Score on a Scale Standard Deviation 28.791	0.56 Score on a Scale Standard Deviation 28.190	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 4 Day 1	-5.24 Score on a Scale Standard Deviation 26.434	-5.29 Score on a Scale Standard Deviation 24.881	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 6 Day 1	-6.43 Score on a Scale Standard Deviation 28.820	-7.49 Score on a Scale Standard Deviation 23.611	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 8 Day 1	-4.91 Score on a Scale Standard Deviation 29.176	-4.11 Score on a Scale Standard Deviation 24.420	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 10 Day 1	-7.95 Score on a Scale Standard Deviation 28.346	-4.76 Score on a Scale Standard Deviation 23.557	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 12 Day 1	-8.33 Score on a Scale Standard Deviation 28.890	-5.26 Score on a Scale Standard Deviation 22.646	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 14 Day 1	-5.50 Score on a Scale Standard Deviation 28.140	-3.56 Score on a Scale Standard Deviation 23.062	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 16 Day 1	-5.86 Score on a Scale Standard Deviation 26.220	-4.44 Score on a Scale Standard Deviation 25.820	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 18 Day 1	-3.15 Score on a Scale Standard Deviation 30.178	-3.21 Score on a Scale Standard Deviation 20.898	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 20 Day 1	-4.47 Score on a Scale Standard Deviation 30.659	-2.85 Score on a Scale Standard Deviation 23.249	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 22 Day 1	-5.49 Score on a Scale Standard Deviation 27.049	-3.54 Score on a Scale Standard Deviation 23.969	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 28 Day 1	-3.00 Score on a Scale Standard Deviation 26.872	-3.03 Score on a Scale Standard Deviation 22.701	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores Cycle 31 Day 1	-10.14 Score on a Scale Standard Deviation 24.995	-7.05 Score on a Scale Standard Deviation 34.696	—	—
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores 60 days post-progression	15.38 Score on a Scale Standard Deviation 19.792	11.46 Score on a Scale Standard Deviation 24.884	—	—

SECONDARY outcome

Timeframe: From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)

Population: All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.

The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=265 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status	19.4 Months Interval 15.7 to 24.9	22.1 Months Interval 17.5 to Not estimable (NA) due to the insufficient number of participants with events	—	—

SECONDARY outcome

Timeframe: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)

The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma. The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= "Not at all", 1= "a little bit", 2= "somewhat", 3= "quite a bit" and 4= "very much". The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma. The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=177 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=190 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 6 Day 1	1.01 Score on a scale Standard Deviation 7.370	1.18 Score on a scale Standard Deviation 6.219	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 16 Day 1	0.93 Score on a scale Standard Deviation 6.451	0.71 Score on a scale Standard Deviation 6.374	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 18 Day 1	1.23 Score on a scale Standard Deviation 7.095	0.47 Score on a scale Standard Deviation 6.152	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 25 Day 1	2.73 Score on a scale Standard Deviation 5.950	0.74 Score on a scale Standard Deviation 6.792	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 28 Day 1	2.46 Score on a scale Standard Deviation 5.195	0.61 Score on a scale Standard Deviation 8.020	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 4 Day 1	0.83 Score on a scale Standard Deviation 6.600	0.87 Score on a scale Standard Deviation 6.185	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 8 Day 1	1.14 Score on a scale Standard Deviation 7.284	1.09 Score on a scale Standard Deviation 5.742	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 10 Day 1	1.52 Score on a scale Standard Deviation 7.314	0.54 Score on a scale Standard Deviation 6.492	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 12 Day 1	1.21 Score on a scale Standard Deviation 7.515	0.47 Score on a scale Standard Deviation 5.974	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 14 Day 1	0.77 Score on a scale Standard Deviation 7.071	0.65 Score on a scale Standard Deviation 6.681	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 20 Day 1	1.28 Score on a scale Standard Deviation 6.634	0.53 Score on a scale Standard Deviation 5.875	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 22 Day 1	1.87 Score on a scale Standard Deviation 6.215	0.79 Score on a scale Standard Deviation 5.970	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 31 Day 1	3.29 Score on a scale Standard Deviation 5.702	1.88 Score on a scale Standard Deviation 6.154	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score Cycle 34 Day 1	-0.50 Score on a scale Standard Deviation 2.121	4.60 Score on a scale Standard Deviation 3.578	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score 30 days post-progression	0.33 Score on a scale Standard Deviation 7.620	-1.07 Score on a scale Standard Deviation 8.590	—	—
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score 60 days post-progression	-2.60 Score on a scale Standard Deviation 5.734	-3.06 Score on a scale Standard Deviation 8.948	—	—

SECONDARY outcome

Timeframe: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)

The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=176 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=190 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 16 Day 1	1.30 Score on a Scale Standard Deviation 18.640	2.79 Score on a Scale Standard Deviation 16.996	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 18 Day 1	2.16 Score on a Scale Standard Deviation 20.762	1.91 Score on a Scale Standard Deviation 16.743	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 20 Day 1	1.34 Score on a Scale Standard Deviation 17.831	1.28 Score on a Scale Standard Deviation 16.108	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 4 Day 1	1.85 Score on a Scale Standard Deviation 16.567	2.16 Score on a Scale Standard Deviation 19.733	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 6 Day 1	1.55 Score on a Scale Standard Deviation 20.751	3.10 Score on a Scale Standard Deviation 16.095	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 8 Day 1	0.39 Score on a Scale Standard Deviation 20.246	2.60 Score on a Scale Standard Deviation 15.200	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 10 Day 1	2.45 Score on a Scale Standard Deviation 19.050	2.52 Score on a Scale Standard Deviation 16.144	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 12 Day 1	1.88 Score on a Scale Standard Deviation 24.653	1.42 Score on a Scale Standard Deviation 15.695	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 14 Day 1	2.62 Score on a Scale Standard Deviation 19.455	1.71 Score on a Scale Standard Deviation 14.337	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 22 Day 1	3.01 Score on a Scale Standard Deviation 19.102	1.55 Score on a Scale Standard Deviation 14.973	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 25 Day 1	4.47 Score on a Scale Standard Deviation 19.489	0.26 Score on a Scale Standard Deviation 14.784	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 28 Day 1	4.20 Score on a Scale Standard Deviation 17.545	-0.39 Score on a Scale Standard Deviation 18.529	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 31 Day 1	6.45 Score on a Scale Standard Deviation 19.561	-0.08 Score on a Scale Standard Deviation 16.747	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score Cycle 34 Day 1	-9.50 Score on a Scale Standard Deviation 14.849	5.60 Score on a Scale Standard Deviation 19.008	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score 30 days post-progression	-4.04 Score on a Scale Standard Deviation 22.033	-10.24 Score on a Scale Standard Deviation 23.532	—	—
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score 60 days post-progression	-19.25 Score on a Scale Standard Deviation 19.923	-8.19 Score on a Scale Standard Deviation 21.192	—	—

SECONDARY outcome

Timeframe: Up to disease progression or death due to any cause, up to 2.8 years (Part 3)

Population: All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) with an evaluable PD-L1 assessment.

PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment. PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having \< 1% expression.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=236 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=241 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression PD-L1 positive (>=1%)	26.6 Months Interval 17.4 to Not estimable (NA) due to the insufficient number of participants with events	15.4 Months Interval 10.2 to 25.3	—	—
Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression PD-L1 negative (<1%)	12.0 Months Interval 10.1 to 15.7	10.3 Months Interval 7.5 to 13.0	—	—

SECONDARY outcome

Timeframe: Up to death due to any cause, assessed up to approximately 7 years

Population: All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) with an evaluable PD-L1 assessment.

Overall survival was defined as the time from date of randomization to date of death due to any cause. OS analysis was performed by PD-L1 subgroup (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having \< 1% expression.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=112 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=138 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Randomized (Part 3): OS by PD-L1 Expression PD-L1 negative (<1%)	41.6 Months Interval 27.6 to Not estimable (NA) due to the insufficient number of participants with events	21.0 Months Interval 16.9 to 33.4	—	—
Randomized (Part 3): OS by PD-L1 Expression PD-L1 positive (>=1%)	NA Months Interval 45.4 to Not estimable (NA) due to the insufficient number of participants with events	61.3 Months Interval 41.2 to Not estimable (NA) due to the insufficient number of participants with events	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Part 1 and 2: All subjects to whom study treatment was assigned and who received any study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Part 3: All subjects randomized to spartalizumab with dabrafenib and trametinib with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Determinant sample: sample that is neither ADA-inconclusive nor unevaluable

Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=26 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=244 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline	0 Participants	0 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).

Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=26 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=244 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Spartalizumab ADA Incidence	0 Participants	5 Participants	55 Participants	—

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days

Population: All subjects who provided at least one evaluable spartalizumab PK concentration at the specified time points.

Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=5 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=17 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=138 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Trough Concentration (Ctrough) for Spartalizumab Cycle 10	62.1 microgram (μg)/miliLiter (mL) Standard Deviation 22.5	68.4 microgram (μg)/miliLiter (mL) Standard Deviation 33.2	63.8 microgram (μg)/miliLiter (mL) Standard Deviation 28.4	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 2	31.9 microgram (μg)/miliLiter (mL) Standard Deviation 4.59	31.5 microgram (μg)/miliLiter (mL) Standard Deviation 20.3	28.4 microgram (μg)/miliLiter (mL) Standard Deviation 13.4	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 3	41.1 microgram (μg)/miliLiter (mL) Standard Deviation 7.07	56.1 microgram (μg)/miliLiter (mL) Standard Deviation 34.2	43.5 microgram (μg)/miliLiter (mL) Standard Deviation 19.1	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 4	47.8 microgram (μg)/miliLiter (mL)	46.9 microgram (μg)/miliLiter (mL) Standard Deviation 18.8	50.5 microgram (μg)/miliLiter (mL) Standard Deviation 24.2	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 5	46.3 microgram (μg)/miliLiter (mL)	56.7 microgram (μg)/miliLiter (mL) Standard Deviation 19.5	56.4 microgram (μg)/miliLiter (mL) Standard Deviation 24.5	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 6	53.8 microgram (μg)/miliLiter (mL) Standard Deviation 16.9	60.9 microgram (μg)/miliLiter (mL) Standard Deviation 23.6	58.8 microgram (μg)/miliLiter (mL) Standard Deviation 26.5	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 7	56.1 microgram (μg)/miliLiter (mL) Standard Deviation 12.1	62.2 microgram (μg)/miliLiter (mL) Standard Deviation 33.3	63.7 microgram (μg)/miliLiter (mL) Standard Deviation 29.6	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 8	57.9 microgram (μg)/miliLiter (mL) Standard Deviation 12.7	65.8 microgram (μg)/miliLiter (mL) Standard Deviation 32.8	64.1 microgram (μg)/miliLiter (mL) Standard Deviation 29.9	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 9	60.2 microgram (μg)/miliLiter (mL) Standard Deviation 30.9	69.5 microgram (μg)/miliLiter (mL) Standard Deviation 25.2	67.8 microgram (μg)/miliLiter (mL) Standard Deviation 33.5	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 11	66.9 microgram (μg)/miliLiter (mL) Standard Deviation 15.8	63.2 microgram (μg)/miliLiter (mL) Standard Deviation 35.8	62.1 microgram (μg)/miliLiter (mL) Standard Deviation 27.9	—
Trough Concentration (Ctrough) for Spartalizumab Cycle 12	67.0 microgram (μg)/miliLiter (mL) Standard Deviation 16.5	61.6 microgram (μg)/miliLiter (mL) Standard Deviation 29.3	60.7 microgram (μg)/miliLiter (mL) Standard Deviation 27.2	—

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days

Population: All subjects who provided at least one evaluable dabrafenib PK concentration at the specified time points.

Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.

Outcome measures

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days

Population: All subjects who provided at least one evaluable trametinib PK concentration at the specified time points.

Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=3 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=14 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=103 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=143 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Pre-dose Plasma Concentration for Trametinib Cycle 4	10.7 ng/mL Standard Deviation 1.64	12.5 ng/mL Standard Deviation 4.84	11.7 ng/mL Standard Deviation 4.62	11.9 ng/mL Standard Deviation 5.04
Pre-dose Plasma Concentration for Trametinib Cycle 5	10.1 ng/mL	12.6 ng/mL Standard Deviation 5.03	11.3 ng/mL Standard Deviation 4.91	11.6 ng/mL Standard Deviation 4.49
Pre-dose Plasma Concentration for Trametinib Cycle 30	10.8 ng/mL	—	9.34 ng/mL Standard Deviation 7.56	10.1 ng/mL Standard Deviation 2.76
Pre-dose Plasma Concentration for Trametinib Cycle 36	8.97 ng/mL	—	—	—
Pre-dose Plasma Concentration for Trametinib Cycle 2	11.7 ng/mL Standard Deviation 4.09	11.2 ng/mL Standard Deviation 3.4	11.5 ng/mL Standard Deviation 4.73	13.9 ng/mL Standard Deviation 9.36
Pre-dose Plasma Concentration for Trametinib Cycle 3	8.34 ng/mL Standard Deviation 0.354	12.2 ng/mL Standard Deviation 2.55	11.4 ng/mL Standard Deviation 5.98	12.3 ng/mL Standard Deviation 5.59
Pre-dose Plasma Concentration for Trametinib Cycle 6	10.0 ng/mL Standard Deviation 1.38	11.8 ng/mL Standard Deviation 3.73	11.6 ng/mL Standard Deviation 5.12	10.9 ng/mL Standard Deviation 3.52
Pre-dose Plasma Concentration for Trametinib Cycle 7	11.6 ng/mL Standard Deviation 3.8	11.8 ng/mL Standard Deviation 5.24	12.0 ng/mL Standard Deviation 4.86	11.0 ng/mL Standard Deviation 4.26
Pre-dose Plasma Concentration for Trametinib Cycle 8	9.24 ng/mL Standard Deviation 3.06	10.2 ng/mL Standard Deviation 4.13	10.3 ng/mL Standard Deviation 3.92	11.3 ng/mL Standard Deviation 4.08
Pre-dose Plasma Concentration for Trametinib Cycle 9	8.73 ng/mL Standard Deviation 3.35	10.5 ng/mL Standard Deviation 4.43	10.9 ng/mL Standard Deviation 4.57	11.6 ng/mL Standard Deviation 4.22
Pre-dose Plasma Concentration for Trametinib Cycle 10	8.24 ng/mL	10.5 ng/mL Standard Deviation 4.02	10.9 ng/mL Standard Deviation 4.47	11.8 ng/mL Standard Deviation 4.26
Pre-dose Plasma Concentration for Trametinib Cycle 11	10.7 ng/mL	11.6 ng/mL Standard Deviation 4.69	10.3 ng/mL Standard Deviation 3.67	11.4 ng/mL Standard Deviation 3.57
Pre-dose Plasma Concentration for Trametinib Cycle 12	10.6 ng/mL Standard Deviation 3.92	11.0 ng/mL Standard Deviation 4.53	10.6 ng/mL Standard Deviation 4.31	11.2 ng/mL Standard Deviation 3.82
Pre-dose Plasma Concentration for Trametinib Cycle 18	10.1 ng/mL	13.0 ng/mL Standard Deviation 4.6	9.66 ng/mL Standard Deviation 3.49	12.1 ng/mL Standard Deviation 5.13
Pre-dose Plasma Concentration for Trametinib Cycle 24	—	13.4 ng/mL Standard Deviation 8.03	10.7 ng/mL Standard Deviation 4.89	10.7 ng/mL Standard Deviation 2.21

SECONDARY outcome

Timeframe: From baseline to end of treatment, assessed up to approximately 7 years

Population: All participants who received at least one dose of study treatment

Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=264 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Number of Participants With Dose Interruptions Spartalizumab (PDR001) · With no dose interruption	4 Participants	11 Participants	120 Participants	170 Participants
Number of Participants With Dose Interruptions Spartalizumab (PDR001) · With at least one dose interruption	5 Participants	16 Participants	147 Participants	94 Participants
Number of Participants With Dose Interruptions Dabrafenib · With no dose interruption	0 Participants	2 Participants	29 Participants	74 Participants
Number of Participants With Dose Interruptions Dabrafenib · With at least one dose interruption	9 Participants	25 Participants	238 Participants	190 Participants
Number of Participants With Dose Interruptions Trametinib · With no dose interruption	0 Participants	1 Participants	29 Participants	64 Participants
Number of Participants With Dose Interruptions Trametinib · With at least one dose interruption	9 Participants	26 Participants	238 Participants	200 Participants

SECONDARY outcome

Timeframe: From baseline to end of treatment, assessed up to approximately 7 years

Population: All participants who received at least one dose of study treatment

Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=264 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Number of Participants With Dose Reductions Dabrafenib · With neither dose reduction nor interruption	0 Participants	2 Participants	25 Participants	68 Participants
Number of Participants With Dose Reductions Dabrafenib · With at least one dose reduction and/or interruption	9 Participants	25 Participants	242 Participants	196 Participants
Number of Participants With Dose Reductions Trametinib · With neither dose reduction nor interruption	0 Participants	1 Participants	28 Participants	63 Participants
Number of Participants With Dose Reductions Trametinib · With at least one dose reduction and/or interruption	9 Participants	26 Participants	239 Participants	201 Participants

SECONDARY outcome

Timeframe: From baseline to end of treatment, assessed up to approximately 7 years

Population: All participants who received at least one dose of study treatment

Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio (expressed as percentage) of dose intensity and planned dose intensity: * Spartalizumab (PDR001) = \[Dose intensity (mg/4W) / planned dose intensity (mg/4W)\]\*100. * Trametinib and Dabrafenib = \[Dose intensity (mg/day) / planned dose intensity (mg/day)\]\*100.

Outcome measures

Outcome measures
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=264 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Relative Dose Intensity Spartalizumab (PDR001)	90.7 Percentage of planned dose intensity Standard Deviation 16.83	91.7 Percentage of planned dose intensity Standard Deviation 10.41	94.4 Percentage of planned dose intensity Standard Deviation 9.21	97.5 Percentage of planned dose intensity Standard Deviation 5.33
Relative Dose Intensity Dabrafenib	62.2 Percentage of planned dose intensity Standard Deviation 26.36	71.3 Percentage of planned dose intensity Standard Deviation 21.13	78.1 Percentage of planned dose intensity Standard Deviation 21.21	89.6 Percentage of planned dose intensity Standard Deviation 15.10
Relative Dose Intensity Trametinib	65.9 Percentage of planned dose intensity Standard Deviation 16.90	76.2 Percentage of planned dose intensity Standard Deviation 17.19	79.8 Percentage of planned dose intensity Standard Deviation 19.58	89.5 Percentage of planned dose intensity Standard Deviation 14.86

Adverse Events

Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD

Serious events: 7 serious events

Other events: 9 other events

Deaths: 2 deaths

Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD

Serious events: 18 serious events

Other events: 27 other events

Deaths: 3 deaths

Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD

Serious events: 150 serious events

Other events: 262 other events

Deaths: 28 deaths

Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD

Serious events: 123 serious events

Other events: 250 other events

Deaths: 33 deaths

Part 1- Safety run-in: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Part 2- Biomarker Cohort: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD(Extended F/Up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Part 3- Arm 1: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 99 deaths

Part 3- Arm 2: Placebo+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 117 deaths

Serious adverse events

Serious adverse events
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 participants at risk Part 1- Safety run-in: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 participants at risk Part 2- Biomarker cohort: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 participants at risk Part 3- Arm 1: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=264 participants at risk Part 3- Arm 2: Placebo + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 1- Safety run-in: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up) Part 1- Safety run-in: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.	Part 2- Biomarker Cohort: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD(Extended F/Up) Part 2- Biomarker cohort: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.	Part 3- Arm 1: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up) Part 3- Arm 1: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.	Part 3- Arm 2: Placebo+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up) Part 3- Arm 2: Placebo + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Angina unstable	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Atrial flutter	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Bradycardia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Cardiac arrest	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Cardiac disorder	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Cardiac failure	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Coronary artery disease	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Coronary artery stenosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Left ventricular dysfunction	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Myocardial infarction	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Sinus node dysfunction	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Sinus tachycardia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Cardiac disorders Tachycardia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Adrenal insufficiency	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Hypophysitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Hypothyroidism	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Angle closure glaucoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Cataract	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Conjunctival haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Detachment of retinal pigment epithelium	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Diplopia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Iridocyclitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Macular detachment	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Retinal degeneration	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Retinal detachment	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Uveitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Vision blurred	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Ascites	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Autoimmune colitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Colitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Constipation	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Enteritis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Inguinal hernia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Intestinal perforation	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Nausea	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Pancreatitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Umbilical hernia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Administration site extravasation	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Asthenia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Chills	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Discomfort	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Fatigue	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders General physical health deterioration	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Generalised oedema	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Influenza like illness	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Malaise	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Multiple organ dysfunction syndrome	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Oedema peripheral	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Pyrexia	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	17.2% 46/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.1% 16/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Cholelithiasis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hepatic failure	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hepatitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hypertransaminasaemia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Liver disorder	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Immune system disorders Contrast media allergy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Immune system disorders Cytokine release syndrome	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Immune system disorders Sarcoidosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Appendicitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Appendicitis perforated	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Atypical pneumonia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Bacterial food poisoning	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Bacterial sepsis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Biliary tract infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations COVID-19	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations COVID-19 pneumonia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Cellulitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Device related infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Empyema	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Enterocolitis infectious	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Erysipelas	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Febrile infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Influenza	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Lower respiratory tract infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Meningitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Peritonitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Pneumonia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Post procedural infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Post procedural sepsis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Pyelonephritis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Rash pustular	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Respiratory tract infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Sepsis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Septic shock	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Skin infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Sweating fever	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Systemic infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Urinary tract infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Urinary tract infection fungal	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Urosepsis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Wound infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Head injury	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Hip fracture	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Overdose	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Post embolisation syndrome	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Alanine aminotransferase abnormal	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Alanine aminotransferase increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Amylase increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Aspartate aminotransferase abnormal	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Aspartate aminotransferase increased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood bilirubin increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood creatine phosphokinase increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood creatinine increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Body temperature increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations C-reactive protein increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Ejection fraction decreased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.7% 15/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Electrocardiogram QT prolonged	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations General physical condition abnormal	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Hepatic enzyme increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Lipase increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Streptococcus test positive	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Transaminases increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Gout	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hyponatraemia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary tract neoplasm	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine neoplasm	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Altered state of consciousness	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Amnesia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Aphasia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Brain oedema	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Cerebral haematoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Cerebral haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Cerebral infarction	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Cerebrovascular accident	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Cognitive disorder	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Dizziness	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Dysarthria	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Epilepsy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Headache	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Hydrocephalus	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Immune-mediated encephalopathy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Intracranial pressure increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Intracranial tumour haemorrhage	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Meningism	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Metabolic encephalopathy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Monoparesis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Nerve compression	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Nervous system disorder	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Neuritis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Neurological decompensation	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Neuropathy peripheral	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Paraesthesia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Partial seizures	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Polyneuropathy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Presyncope	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Sciatica	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Seizure	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Spinal cord compression	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Syncope	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Tremor	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Anxiety	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Confusional state	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Delirium	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Suicide attempt	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Acute kidney injury	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Calculus urinary	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Haematuria	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Immune-mediated nephritis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Nephritis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Renal colic	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Renal failure	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Renal impairment	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Urethral stenosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Urinary retention	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Reproductive system and breast disorders Prostatic disorder	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Autoimmune lung disease	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Rash	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Aneurysm ruptured	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Deep vein thrombosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Embolism	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Haematoma	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Hypertension	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Hypovolaemic shock	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Lymphoedema	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Shock haemorrhagic	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Vasculitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.

Other adverse events

Other adverse events
Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=9 participants at risk Part 1- Safety run-in: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=27 participants at risk Part 2- Biomarker cohort: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=267 participants at risk Part 3- Arm 1: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=264 participants at risk Part 3- Arm 2: Placebo + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up	Part 1- Safety run-in: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up) Part 1- Safety run-in: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.	Part 2- Biomarker Cohort: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD(Extended F/Up) Part 2- Biomarker cohort: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.	Part 3- Arm 1: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up) Part 3- Arm 1: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.	Part 3- Arm 2: Placebo+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up) Part 3- Arm 2: Placebo + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.
Blood and lymphatic system disorders Anaemia	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	37.0% 10/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.4% 49/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.7% 31/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Leukopenia	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.6% 23/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.3% 14/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Lymphopenia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.5% 20/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Neutropenia	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	16.5% 44/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.0% 37/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Thrombocytopenia	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	9.0% 24/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.8% 10/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Thrombocytosis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Ear and labyrinth disorders Ear congestion	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Ear and labyrinth disorders Ear pain	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Ear and labyrinth disorders Motion sickness	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Hyperthyroidism	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.7% 18/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Hypophysitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Hypothyroidism	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.5% 20/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Inappropriate antidiuretic hormone secretion	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Endocrine disorders Thyroiditis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Dry eye	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	33.3% 9/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Iridocyclitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Myopia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Ocular discomfort	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Papilloedema	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Periorbital oedema	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Photophobia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.2% 6/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Retinal haemorrhage	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Retinopathy	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Uveitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Vision blurred	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.9% 13/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Visual impairment	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 10/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Eye disorders Vitreal cells	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal distension	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.9% 29/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	9.8% 26/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	9.7% 26/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Cheilitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Constipation	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	25.9% 7/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	15.0% 40/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	15.2% 40/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Diarrhoea	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	33.3% 9/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	36.7% 98/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	26.5% 70/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Dry mouth	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	22.2% 6/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.2% 22/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.9% 13/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.7% 18/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.9% 13/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Glossitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Nausea	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	29.6% 8/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	33.7% 90/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	29.5% 78/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Odynophagia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Trichoglossia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Gastrointestinal disorders Vomiting	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	37.0% 10/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	25.8% 69/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.9% 50/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Asthenia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	40.7% 11/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	27.3% 73/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	20.8% 55/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Axillary pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Chills	88.9% 8/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	33.3% 9/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	32.2% 86/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	23.9% 63/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Face oedema	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Fatigue	77.8% 7/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	40.7% 11/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	26.6% 71/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	26.1% 69/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Influenza like illness	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.5% 28/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.7% 15/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Non-cardiac chest pain	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Oedema	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.7% 7/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Oedema due to cardiac disease	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Oedema peripheral	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.2% 30/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.6% 28/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Pain	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.8% 10/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Pyrexia	100.0% 9/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	85.2% 23/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	70.8% 189/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	54.9% 145/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
General disorders Xerosis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.7% 7/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hepatic function abnormal	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hepatic steatosis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hepatitis	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Hypertransaminasaemia	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.2% 6/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Hepatobiliary disorders Immune-mediated hepatitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Immune system disorders Cytokine release syndrome	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Immune system disorders Sarcoidosis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Bronchitis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.5% 20/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations COVID-19	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.7% 18/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.9% 13/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Candida infection	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Cellulitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.2% 6/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Conjunctivitis	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.2% 14/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Folliculitis	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.2% 14/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Fungal skin infection	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Furuncle	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Gastrointestinal viral infection	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Nasopharyngitis	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.5% 28/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	12.1% 32/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Oral candidiasis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Oral herpes	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Otitis media	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Otitis media chronic	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Paronychia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Pneumonia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Postoperative wound infection	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Rhinitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.7% 18/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.8% 10/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Sinusitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.5% 12/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Tonsillitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Upper respiratory tract infection	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Urinary tract infection	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	9.7% 26/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	9.5% 25/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Viral infection	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Viral pharyngitis	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Viral rhinitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Infections and infestations Viral upper respiratory tract infection	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Compression fracture	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Contusion	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Procedural pain	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Radiation skin injury	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Alanine aminotransferase increased	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	25.9% 7/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	25.1% 67/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	15.5% 41/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Amylase increased	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	17.2% 46/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.3% 22/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Aspartate aminotransferase increased	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	28.5% 76/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	20.1% 53/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood albumin decreased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood alkaline phosphatase increased	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	12.4% 33/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.6% 28/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood cholesterol increased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.5% 12/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood creatine phosphokinase increased	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	33.3% 9/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	28.1% 75/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	27.3% 72/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood creatinine increased	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	9.0% 24/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood lactate dehydrogenase increased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.1% 27/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.0% 21/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood sodium decreased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood testosterone decreased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood thyroid stimulating hormone decreased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Blood triglycerides increased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations C-reactive protein increased	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.5% 12/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Ejection fraction decreased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.7% 18/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.0% 21/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Gamma-glutamyltransferase increased	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.6% 20/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Globulins increased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Hepatic enzyme increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Lipase increased	55.6% 5/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	24.7% 66/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.4% 38/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Lymphocyte count decreased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Myoglobin blood increased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Neutrophil count decreased	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Transaminases increased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations Weight decreased	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Investigations White blood cell count decreased	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Decreased appetite	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	25.9% 7/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	12.4% 33/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.2% 27/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypercholesterolaemia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hyperglycaemia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	13.9% 37/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	9.1% 24/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypokalaemia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.6% 15/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hyponatraemia	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.2% 14/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.1% 16/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Iron deficiency	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 6/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	55.6% 15/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	32.6% 87/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	30.3% 80/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Arthritis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.2% 6/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Back pain	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	12.4% 33/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.0% 37/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Flank pain	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Groin pain	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Joint swelling	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.2% 6/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Limb discomfort	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	12.0% 32/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.6% 28/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Myalgia	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	29.6% 8/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	16.1% 43/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.0% 37/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Osteopenia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	22.2% 6/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.6% 31/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.7% 23/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Anosmia	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Aphasia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Dizziness	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.9% 21/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.7% 23/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Dizziness postural	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Dysaesthesia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Dysgeusia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.9% 13/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Headache	55.6% 5/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	29.6% 8/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	30.0% 80/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	28.0% 74/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Memory impairment	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Migraine	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Paraesthesia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.2% 14/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.3% 14/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Peroneal nerve palsy	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Nervous system disorders Syncope	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Anxiety	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.5% 12/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.1% 16/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Bradyphrenia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Disorientation	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Psychiatric disorders Insomnia	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.2% 22/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.8% 18/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Acute kidney injury	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.2% 6/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Dysuria	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.2% 14/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Haematuria	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Renal and urinary disorders Nocturia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Reproductive system and breast disorders Ovarian cyst	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 6/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	44.4% 12/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	23.6% 63/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	18.6% 49/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	13.9% 37/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.4% 30/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 10/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.5% 28/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.5% 12/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 10/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Sinus congestion	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.4% 17/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.9% 13/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.3% 14/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.2% 14/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.7% 15/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Eczema	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.1% 16/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	10.1% 27/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Erythema nodosum	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.2% 14/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Granuloma annulare	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Hyperhidrosis	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	5.3% 14/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Hyperkeratosis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Ingrowing nail	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Night sweats	33.3% 3/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 10/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	4.2% 11/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Palmoplantar keratoderma	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.76% 2/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Panniculitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.0% 8/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Photosensitivity reaction	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.4% 9/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	29.6% 8/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	19.1% 51/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	8.3% 22/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Rash	44.4% 4/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	48.1% 13/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	28.5% 76/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	25.8% 68/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Rash erythematous	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Rash macular	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.75% 2/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	6.0% 16/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.3% 6/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Sensitive skin	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Skin disorder	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Stasis dermatitis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.37% 1/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.38% 1/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Urticaria	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.2% 6/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.7% 7/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.9% 21/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Hot flush	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.9% 5/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Hypertension	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.5% 20/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	12.9% 34/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Hypotension	22.2% 2/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	3.7% 10/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.7% 7/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Lymphoedema	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	2.6% 7/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.5% 4/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Orthostatic hypotension	0.00% 0/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	1.1% 3/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Vascular disorders Superficial vein thrombosis	11.1% 1/9 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/267 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	0.00% 0/264 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.	— 0/0 • Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months. Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=4 Participants In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=18 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=127 Participants In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)	Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD n=162 Participants In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Pre-dose Plasma Concentration for Dabrafenib Cycle 5	28.8 nanogram (ng)/ miliLiter (mL) Standard Deviation 30.6	152 nanogram (ng)/ miliLiter (mL) Standard Deviation 293	130 nanogram (ng)/ miliLiter (mL) Standard Deviation 317	152 nanogram (ng)/ miliLiter (mL) Standard Deviation 363
Pre-dose Plasma Concentration for Dabrafenib Cycle 6	15.1 nanogram (ng)/ miliLiter (mL) Standard Deviation 16.3	73.7 nanogram (ng)/ miliLiter (mL) Standard Deviation 131	198 nanogram (ng)/ miliLiter (mL) Standard Deviation 521	94.6 nanogram (ng)/ miliLiter (mL) Standard Deviation 186
Pre-dose Plasma Concentration for Dabrafenib Cycle 10	24.5 nanogram (ng)/ miliLiter (mL) Standard Deviation 9.19	60.0 nanogram (ng)/ miliLiter (mL) Standard Deviation 28.3	167 nanogram (ng)/ miliLiter (mL) Standard Deviation 472	122 nanogram (ng)/ miliLiter (mL) Standard Deviation 266
Pre-dose Plasma Concentration for Dabrafenib Cycle 24	—	91.5 nanogram (ng)/ miliLiter (mL) Standard Deviation 98.3	147 nanogram (ng)/ miliLiter (mL) Standard Deviation 344	60.2 nanogram (ng)/ miliLiter (mL) Standard Deviation 67.9
Pre-dose Plasma Concentration for Dabrafenib Cycle 2	33.7 nanogram (ng)/ miliLiter (mL) Standard Deviation 27.4	149 nanogram (ng)/ miliLiter (mL) Standard Deviation 391	208 nanogram (ng)/ miliLiter (mL) Standard Deviation 473	234 nanogram (ng)/ miliLiter (mL) Standard Deviation 475
Pre-dose Plasma Concentration for Dabrafenib Cycle 3	25.5 nanogram (ng)/ miliLiter (mL) Standard Deviation 10.4	183 nanogram (ng)/ miliLiter (mL) Standard Deviation 469	192 nanogram (ng)/ miliLiter (mL) Standard Deviation 607	135 nanogram (ng)/ miliLiter (mL) Standard Deviation 266
Pre-dose Plasma Concentration for Dabrafenib Cycle 4	23.0 nanogram (ng)/ miliLiter (mL) Standard Deviation 15.8	372 nanogram (ng)/ miliLiter (mL) Standard Deviation 811	169 nanogram (ng)/ miliLiter (mL) Standard Deviation 404	167 nanogram (ng)/ miliLiter (mL) Standard Deviation 328
Pre-dose Plasma Concentration for Dabrafenib Cycle 7	20.9 nanogram (ng)/ miliLiter (mL) Standard Deviation 13.9	40.0 nanogram (ng)/ miliLiter (mL) Standard Deviation 20.0	180 nanogram (ng)/ miliLiter (mL) Standard Deviation 510	121 nanogram (ng)/ miliLiter (mL) Standard Deviation 279
Pre-dose Plasma Concentration for Dabrafenib Cycle 8	22.9 nanogram (ng)/ miliLiter (mL) Standard Deviation 16.8	28.0 nanogram (ng)/ miliLiter (mL) Standard Deviation 10.4	173 nanogram (ng)/ miliLiter (mL) Standard Deviation 532	97.2 nanogram (ng)/ miliLiter (mL) Standard Deviation 177
Pre-dose Plasma Concentration for Dabrafenib Cycle 9	22.3 nanogram (ng)/ miliLiter (mL) Standard Deviation 7.59	43.3 nanogram (ng)/ miliLiter (mL) Standard Deviation 40.6	143 nanogram (ng)/ miliLiter (mL) Standard Deviation 394	133 nanogram (ng)/ miliLiter (mL) Standard Deviation 259
Pre-dose Plasma Concentration for Dabrafenib Cycle 11	154 nanogram (ng)/ miliLiter (mL) Standard Deviation 250	33.8 nanogram (ng)/ miliLiter (mL) Standard Deviation 22.6	174 nanogram (ng)/ miliLiter (mL) Standard Deviation 667	119 nanogram (ng)/ miliLiter (mL) Standard Deviation 238
Pre-dose Plasma Concentration for Dabrafenib Cycle 12	10.9 nanogram (ng)/ miliLiter (mL) Standard Deviation 10.3	41.3 nanogram (ng)/ miliLiter (mL) Standard Deviation 37.2	148 nanogram (ng)/ miliLiter (mL) Standard Deviation 396	146 nanogram (ng)/ miliLiter (mL) Standard Deviation 295
Pre-dose Plasma Concentration for Dabrafenib Cycle 18	19.0 nanogram (ng)/ miliLiter (mL)	50.6 nanogram (ng)/ miliLiter (mL) Standard Deviation 49.7	180 nanogram (ng)/ miliLiter (mL) Standard Deviation 618	167 nanogram (ng)/ miliLiter (mL) Standard Deviation 385
Pre-dose Plasma Concentration for Dabrafenib Cycle 30	40.2 nanogram (ng)/ miliLiter (mL)	—	226 nanogram (ng)/ miliLiter (mL) Standard Deviation 488	47.6 nanogram (ng)/ miliLiter (mL) Standard Deviation 23.2
Pre-dose Plasma Concentration for Dabrafenib Cycle 36	47.6 nanogram (ng)/ miliLiter (mL)	—	—	—