Trial Outcomes & Findings for A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (NCT NCT02616185)

Last Updated: 2023-11-02

Results Overview

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

91 participants

Primary outcome timeframe

Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum)

Results posted on

2023-11-02

Participant Flow

A total of 123 participants were screened and 91 of them were assigned and treated in this study.

Participant milestones

Participant milestones
Measure	Cohort 1A: Adenovirus C68 (AdC68) 4x10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg Participants with metastatic castrate resistant prostate cancer (mCRPC) in Cohort 1A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 4x10\^11 VP Intramuscularly (IM) on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 1A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg Participants with mCRPC in Cohort 2A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 2A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 80 mg Participants with mCRPC in Cohort 3A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered subcutaneously (SC) after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3A entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 6A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 6A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg Participants with biochemical relapse (BCR) of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 3B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3B entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Overall Study STARTED	3	4	6	8	14	3	20	18	15
Overall Study COMPLETED	2	3	3	3	5	2	12	5	9
Overall Study NOT COMPLETED	1	1	3	5	9	1	8	13	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1A: Adenovirus C68 (AdC68) 4x10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg Participants with metastatic castrate resistant prostate cancer (mCRPC) in Cohort 1A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 4x10\^11 VP Intramuscularly (IM) on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 1A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg Participants with mCRPC in Cohort 2A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 2A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 80 mg Participants with mCRPC in Cohort 3A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered subcutaneously (SC) after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3A entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 6A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 6A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg Participants with biochemical relapse (BCR) of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 3B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3B entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Overall Study Death	0	0	0	1	2	0	0	2	1
Overall Study Study terminated by sponsor	0	0	1	0	0	0	5	2	0
Overall Study Participant refused further follow-up	1	1	2	3	4	0	3	4	3
Overall Study Not reported	0	0	0	1	3	1	0	5	2

Baseline Characteristics

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1A: AdC68 4x10^11 VP + pDNA 5 mg n=3 Participants Participants with mCRPC in Cohort 1A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 4x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 1A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg n=4 Participants Participants with mCRPC in Cohort 2A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 2A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=6 Participants Participants with mCRPC in Cohort 3A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3A entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=8 Participants Participants with mCRPC in Cohort 6A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 6A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=14 Participants Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg n=3 Participants Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=18 Participants Participants with mCRPC in Cohort 3B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3B entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Total n=91 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	22 Participants n=64 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants	3 Participants n=10 Participants	14 Participants n=115 Participants	15 Participants n=6 Participants	11 Participants n=6 Participants	69 Participants n=64 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	14 Participants n=21 Participants	3 Participants n=10 Participants	20 Participants n=115 Participants	18 Participants n=6 Participants	15 Participants n=6 Participants	91 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	14 Participants n=21 Participants	3 Participants n=10 Participants	18 Participants n=115 Participants	17 Participants n=6 Participants	15 Participants n=6 Participants	88 Participants n=64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	12 Participants n=21 Participants	2 Participants n=10 Participants	19 Participants n=115 Participants	13 Participants n=6 Participants	13 Participants n=6 Participants	79 Participants n=64 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=6 Participants	2 Participants n=6 Participants	11 Participants n=64 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum)

Population: Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 immune checkpoint inhibitor \[ICI\]), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at recommended Phase 2 dose \[RP2D\] dose).

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=56 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=32 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with all-causality AEs	55 Participants	20 Participants	15 Participants	32 Participants	—	—	—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with treatment-related AEs	51 Participants	19 Participants	15 Participants	31 Participants	—	—	—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with all-causality SAEs	16 Participants	2 Participants	6 Participants	11 Participants	—	—	—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with treatment-related SAEs	11 Participants	0 Participants	6 Participants	9 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. Grades of AEs were defined by NCI CTCAE v 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-emergent adverse events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=56 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=32 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With AEs as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) (Grade >= 3) Grade 3 or Grade 4 (all-causality)	33 Participants	10 Participants	11 Participants	21 Participants	—	—	—
Number of Participants With AEs as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) (Grade >= 3) Grade 3 or Grade 4 (treatment-related)	23 Participants	6 Participants	10 Participants	17 Participants	—	—	—
Number of Participants With AEs as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) (Grade >= 3) Grade 5 (all-causality)	4 Participants	0 Participants	1 Participants	3 Participants	—	—	—
Number of Participants With AEs as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) (Grade >= 3) Grade 5 (treatment-related)	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Population: Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. or this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 immune checkpoint inhibitor \[ICI\]), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at recommended Phase 2 dose \[RP2D\] dose).

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=56 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=32 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With AEs Leading to Discontinuation or Dose Reduction Number of participants with permanent discontinuations	16 Participants	1 Participants	10 Participants	11 Participants	—	—	—
Number of Participants With AEs Leading to Discontinuation or Dose Reduction Number of participants with temporary discontinuations	17 Participants	5 Participants	5 Participants	9 Participants	—	—	—
Number of Participants With AEs Leading to Discontinuation or Dose Reduction Number of participants with dose reductions	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: The first 28 days following the first AdC68 vaccination (on Cycle 1 Day 1)

Population: Per protocol analysis set: all enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 and did not have major protocol deviations during the 28 days after the first vaccination. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

The following AEs occurring in the first 28 days following the first AdC68 vaccination and not related to disease/progression were DLTs: (a) hematologic (Cohorts 1A to 3A and Cohorts 6A to 9A): Grade 3 neutropenia lasting \>7 days, febrile neutropenia, Grade \>=3 neutropenic infection, Grade \>=3 thrombocytopenia, Grade \>=3 anemia lasting \>7 days, Grade \>=3 lymphopenia lasting \>14 days; (b) non-hematologic (all cohorts): Grade \>=3 laboratory abnormalities either associated with symptoms or associated with worsening of an existing condition or that suggested a new disease process or that required additional active management, Grade \>=3 toxicities, Grade 3 flu like symptoms lasting \>3 days, fever of \>40.0 degree Celsius lasting \>3 days. Other clinically important or persistent toxicities at discretion of investigator and Pfizer.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=54 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=32 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With Dose-Limiting Toxicities (DLTs)	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Population: Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Hematology parameters included hemoglobin, platelets, white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=56 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=32 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4) Hemoglobin increased	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4) Anemia	2 Participants	0 Participants	0 Participants	2 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4) Lymphocyte count increased	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4) Lymphopenia	7 Participants	2 Participants	2 Participants	4 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4) Neutrophils (absolute)	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4) Platelets	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4) White blood cells	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Population: Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Chemistry parameters included aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (or urea), creatinine, uric acid, glucose, albumin, phosphorous or phosphate, lactate dehydrogenase, lipase, bicarbonate or carbon dioxide, total protein, TSH (if abnormal, reflex free T4 and free T3).

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=56 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=32 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypernatremia	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Alanine aminotransferase	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Bilirubin (total)	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypocalcemia	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypoglycemia	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypokalemia	3 Participants	0 Participants	0 Participants	2 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypomagnesemia	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypoalbuminemia	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypermagnesemia	7 Participants	8 Participants	6 Participants	1 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypercalcemia	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hyperglycemia	4 Participants	0 Participants	0 Participants	2 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hyperkalemia	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Alkaline phosphatase	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Amylase	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Aspartate aminotransferase	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Creatinine	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hyponatremia	0 Participants	1 Participants	2 Participants	0 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypophosphatemia	2 Participants	5 Participants	4 Participants	1 Participants	—	—	—
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Lipase	9 Participants	3 Participants	2 Participants	6 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Population: Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=56 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=32 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With Laboratory Abnormalities in Urinalysis (Grade 3 or 4)	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.

Population: All enrolled participants in Part A who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. Number of Participants Analyzed = number of participants evaluable for this OM; Number Analyzed = number of participants evaluable for this OM at the time point specified.

T cell response to PSA was determined by assaying peripheral blood mononuclear cell (PBMC) samples for cellular immune responses against PSA antigens and was determined as the frequency of interferon-gamma (IFN-γ) spot forming cells (SFC)/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=3 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=5 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=1 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=2 Participants Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg n=2 Participants Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Change From Baseline in T Cell Response to Prostate Specific Antigen (PSA) in Part A Cycle 1 Day 1 Compared With Cycle 1 Day 71	2.83 SFC/10^6 PBMCS Standard Deviation 4.907	4.17 SFC/10^6 PBMCS Standard Deviation 7.217	1.70 SFC/10^6 PBMCS Standard Deviation 3.801	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	24.25 SFC/10^6 PBMCS Standard Deviation 34.295	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	—
Change From Baseline in T Cell Response to Prostate Specific Antigen (PSA) in Part A Cycle 2 Day 1 Compared With Cycle 2 Day 99	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	5.50 SFC/10^6 PBMCS Standard Deviation 9.526	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	—	—	—	—

SECONDARY outcome

Timeframe: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.

T cell response to PSCA was determined by assaying PBMC samples for cellular immune responses against PSCA antigens and was determined as the frequency of IFN-γ SFC/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=3 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=5 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=1 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=2 Participants Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg n=2 Participants Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Change From Baseline in T Cell Response to Prostate Stem Cell Antigen (PSCA) in Part A Cycle 1 Day 1 Compared With Cycle 1 Day 71	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	1.70 SFC/10^6 PBMCS Standard Deviation 3.801	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	—
Change From Baseline in T Cell Response to Prostate Stem Cell Antigen (PSCA) in Part A Cycle 2 Day 1 Compared With Cycle 2 Day 99	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	—	—	—	—

SECONDARY outcome

Timeframe: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.

T cell response to PSMA was determined by assaying PBMC samples for cellular immune responses against PSMA antigens and was determined as the frequency of IFN-γ SFC/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=3 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=5 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=1 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=2 Participants Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg n=2 Participants Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Change From Baseline in T Cell Response to Prostate Specific Membrane Antigen (PSMA) in Part A Cycle 1 Day 1 Compared With Cycle 1 Day 71	5.50 SFC/10^6 PBMCS Standard Deviation 9.526	28.00 SFC/10^6 PBMCS Standard Deviation 48.497	4.30 SFC/10^6 PBMCS Standard Deviation 12.736	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	—
Change From Baseline in T Cell Response to Prostate Specific Membrane Antigen (PSMA) in Part A Cycle 2 Day 1 Compared With Cycle 2 Day 99	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	36.00 SFC/10^6 PBMCS Standard Deviation 62.354	NA SFC/10^6 PBMCS Standard Deviation NA Titers were below the assay detection limit.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.

Population: All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 3A, 6A, 7A, and 9A were treated with tremelimumab, thus included in this outcome measure. Summary statistics for Cohort 6A, 7A, and 9A are not presented since no participants had reportable parameter values.

Cmax was defined as the maximum observed plasma concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=6 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Maximum Observed Plasma Concentration (Cmax) of Tremelimumab in Part A	4360 ng/mL Geometric Coefficient of Variation 31	—	—	—	—	—	—

SECONDARY outcome

Population: All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 3, 6, 7, and 9 were treated with tremelimumab, thus included in this outcome measure. Summary statistics for Cohort 6A, 7A, and 9A are not presented since no participants had reportable parameter values.

Tmax was defined as the time to reach maximum observed plasma concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=6 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tremelimumab in Part A	307 Hour Interval 165.0 to 477.0	—	—	—	—	—	—

SECONDARY outcome

AUClast was defined as the area under the curve from time zero to last quantifiable concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=6 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tremelimumab in Part A	2423000 ng*hr/mL Geometric Coefficient of Variation 34	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose on Cycle 2 Day 1

Population: PK parameter analysis population: all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Cohort 3A, 6A, 7A, 9A, 1B, 3B, and 5B were treated with tremelimumab, thus included in this outcome measure. Number of Participants Analyzed = Number of participants who had non-missing data and were evaluable for this OM.

Pre-dose tremelimumab concentration on Cycle 2 Day 1 is presented here as Ctrough. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected. Summary statistics of Ctrough were not calculated if number of observations above lower lit of quantification (NALQ)=0 or \<=3 participants had non-missing data.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=2 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=2 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=6 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=1 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=11 Participants Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg n=9 Participants Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=4 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Trough Concentrations (Ctrough) After Multiple Dosing of Tremelimumab	NA ng/mL Standard Deviation NA Summary statistics were not computed for PK parameters when fewer than 3 participants had non-missing data. As per the statistical analysis plan of this study, data are considered not sufficient to calculate scientifically meaningful mean and standard deviation when sample size is less than 3.	NA ng/mL Standard Deviation NA Summary statistics were not computed for PK parameters when fewer than 3 participants had non-missing data. As per the statistical analysis plan of this study, data are considered not sufficient to calculate scientifically meaningful mean and standard deviation when sample size is less than 3.	5130 ng/mL Standard Deviation 1844.4	NA ng/mL Standard Deviation NA Summary statistics were not computed for PK parameters when fewer than 3 participants had non-missing data. As per the statistical analysis plan of this study, data are considered not sufficient to calculate scientifically meaningful mean and standard deviation when sample size is less than 3.	4750 ng/mL Standard Deviation 2573.5	4849 ng/mL Standard Deviation 2726.7	5320 ng/mL Standard Deviation 1114.5

SECONDARY outcome

Population: All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 6A, 7A, and 9A were treated with PF-06801591, thus included in this outcome measure.

Cmax was defined as the maximum observed plasma concentration. Blood samples (approximately 5 mL) to provide serum for the analysis of PF-06801591 concentrations were collected.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=8 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=14 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Cmax of PF-06801591 in Part A	8507 ng/mL Geometric Coefficient of Variation 48	19960 ng/mL Geometric Coefficient of Variation 40	8899 ng/mL Geometric Coefficient of Variation 41	—	—	—	—

SECONDARY outcome

Population: All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 6A, 7A, and 9A were treated with PF-06801591, thus included in this outcome measure.

Tmax was defined as the time at which Cmax occurred. Blood samples (approximately 5 mL) to provide serum for the analysis of PF- 06801591 concentrations were collected.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=8 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=14 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Tmax of PF-06801591 in Part A	164 Hour Interval 89.6 to 380.0	188 Hour Interval 67.3 to 378.0	166 Hour Interval 71.0 to 166.0	—	—	—	—

SECONDARY outcome

Population: All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 6A, 7A, and 9A were treated with PF-06801591, thus included in this outcome measure.

AUClast was defined as the area under the curve from time zero to last quantifiable concentration. Blood samples (approximately 5 mL) to provide serum for the analysis of PF-06801591 concentrations were collected. The geometric mean and geometric coefficient of variation of AUClast for Cohort 9A were not presented because fewer than 3 participants had reportable parameter values.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=7 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=13 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=2 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
AUClast of PF-06801591 in Part A	4095000 ng*hr/mL Geometric Coefficient of Variation 43	10370000 ng*hr/mL Geometric Coefficient of Variation 42	NA ng*hr/mL Geometric Coefficient of Variation NA Fewer than 3 participants had reportable parameter values.	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose on Cycle 2 Day 1

Population: PK parameter analysis population: all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Cohort 6A, 7A, 9A, 3B, and 5B were treated with PF-06801591, thus included in this outcome measure.

Pre-dose PF-06801591 concentration on Cycle 2 Day 1 is presented here as Ctrough. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of PF-06801591 PK analysis were collected.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=2 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=6 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=1 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=10 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=4 Participants Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Ctrough of PF-06801591	NA ng/mL Standard Deviation NA Summary statistics were not computed for PK parameters when fewer than 3 participants had non-missing data. As per the statistical analysis plan of this study, data are considered not sufficient to calculate scientifically meaningful mean and standard deviation when sample size is less than 3.	6873 ng/mL Standard Deviation 9097.8	NA ng/mL Standard Deviation NA Summary statistics were not computed for PK parameters when fewer than 3 participants had non-missing data. As per the statistical analysis plan of this study, data are considered not sufficient to calculate scientifically meaningful mean and standard deviation when sample size is less than 3.	20880 ng/mL Standard Deviation 12114	3472 ng/mL Standard Deviation 5085.7	—	—

SECONDARY outcome

Timeframe: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect ADA were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B. Participants were considered ADA-positive if sample titer (log10) \>=1.48; participants were considered ADA-negative if sample titer (log10) \<1.48.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=49 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=35 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=81 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With Anti-Drug Antibody (ADA) Against Tremelimumab	6 Participants	11 Participants	1 Participants	16 Participants	—	—	—

SECONDARY outcome

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Treatment-induced ADA was defined as baseline titer missing or negative and participant had \>=1 post-treatment positive titer. Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect ADA were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=6 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=11 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=1 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=16 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Titer of Treatment-Induced ADA Against Tremelimumab	2.81 1/dilution Interval 2.68 to 2.91	2.34 1/dilution Interval 2.15 to 2.79	2.68 1/dilution Interval 2.68 to 2.68	2.70 1/dilution Interval 2.2 to 2.87	—	—	—

SECONDARY outcome

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect NAb were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B. Nab against tremelimumab was not examined due to business reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Participants were considered ADA-positive if sample titer (log10) \>=99; Participants were considered ADA-negative if sample titer (log10) \<99. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of ADA against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=43 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=32 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=26 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants With ADA Against PF-06801591	5 Participants	8 Participants	3 Participants	10 Participants	—	—	—

SECONDARY outcome

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Treatment-induced ADA was defined as baseline titer missing or negative and participant had \>=1 post-treatment positive titer. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of ADA against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=5 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=6 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=8 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Titer of Treatment-Induced ADA Against PF-06801591	880 1/dilution Interval 790.0 to 16800.0	2010 1/dilution Interval 797.0 to 5070.0	790 1/dilution Interval 99.0 to 16800.0	2010 1/dilution Interval 838.5 to 6295.0	—	—	—

SECONDARY outcome

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of NAb against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B. Nab against PF-06801591 was not examined due to business reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Population: All enrolled participants in Cohort 1A, 2A, 3A, 6A, 7A, 9A, and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

ORR was defined as the percentage of participants with best overall response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=32 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=54 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Cohort 7A and 3B Combined and All mCRPC Patients	9.4 Percentage of participants Interval 2.0 to 25.0	5.6 Percentage of participants Interval 1.2 to 15.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

DOR was defined as the time from first documentation of confirmed CR or PR to date of first documentation of progressive disease (PD) or death due to any cause according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all measurable target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. PD was defined as \>=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. Unequivocal progression of pre existing lesions for non-target disease.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=3 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Duration of Response (DOR) by RECIST v1.1 in Cohort 7A and 3B Combined and All mCRPC Patients	169 Days Interval 119.0 to 224.0	169 Days Interval 119.0 to 224.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Immune-related confirmed ORR was defined as the percentage of participants with objective response based assessment of confirmed immune related complete response (irCR) or confirmed immune related partial response (irPR) according to irRECIST v1.1. Per irRECIST v1.1: irCR was defined as complete disappearance of all lesions and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. irPR was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions must decrease \>=30%.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=32 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=54 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Immune-Related Confirmed ORR by Immune Related Response Evaluation Criteria in Solid Tumors Version 1.1 (irRECIST v1.1) in Cohort 7A and 3B Combined and All mCRPC Patients	9.4 Percentage of participants Interval 2.0 to 25.0	5.6 Percentage of participants Interval 1.2 to 15.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Immune-related confirmed DOR was defined as the time from first documentation of confirmed irCR or confirmed irPR to date of first documentation of immune related progressive disease (irPD) or death due to any cause according to irRECIST. Per irRECIST v1.1: irCR was defined as complete disappearance of all lesions and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. irPR was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions must decrease \>=30%. irPD was defined as sum of the diameters of target and new measurable lesions must increase \>=20%, confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=3 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Immune-Related Confirmed DOR by irRECIST v1.1 in Cohort 7A and 3B Combined and All mCRPC Patients	169 Days Interval 119.0 to 224.0	169 Days Interval 119.0 to 224.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Population: All enrolled participants in Cohort 7A and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

Number of participants with bone progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3). Per PCWG3, progressing disease on bone scan was considered when at least two new lesions relative to the first post treatment scan was confirmed on a subsequent scan (6 or more weeks later).

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=32 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Patients With Bone Progression Per Prostrate Cancer Working Group 3 (PCWG3) Criteria in Cohort 7A and 3B Combined	2 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 6 months after EOT (52 months in maximum)

Radiographic Progression Free Survival (rPFS) per RECIST v1.1. rPFS was defined as the time from first dose of study treatment to date of first documentation of radiographic PD or death due to any cause, whichever occurs first. Per RECIST v1.1, PD was defined as \>=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. Unequivocal progression of pre existing lesions for non-target disease. The Kaplan Meier estimate of median rPFS was presented here.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=32 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=54 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=20 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined n=15 Participants This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Radiographic Progression Free Survival (rPFS) Per RECIST v1.1 in Cohort 7A and 3B Combined , All mCRPC Patients, Cohort 1B, and Cohort 5B	5.6 Months Interval 2.0 to Not estimable based on Based on the Brookmeyer and Crowley method.	5.6 Months Interval 3.5 to Not estimable based on Based on the Brookmeyer and Crowley method.	NA Months Interval 10.2 to Not estimable based on Based on the Brookmeyer and Crowley method.	NA Months Not estimable based on Based on the Brookmeyer and Crowley method.	—	—	—

SECONDARY outcome

Timeframe: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.

Population: All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSA-50 response rate was defined as the proportion of patients whose on-study PSA declined from baseline by at least 50% at two consecutive measurements at least 3 weeks apart, prior to other systematic anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=18 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Number of Participants Achieving Central PSA Response >= 50% Decline From Baseline (PSA-50) in Part B	5 Participants	1 Participants	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 29, 57 of Cycle 1 and Cycle 2.

Duration of PSA-50 response was defined as the period from the first measurement when PSA-50 response was achieved to the measurement when PSA-50 response no longer held.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=5 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=1 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=3 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Duration of PSA-50 Response in Part B	6.9 Months Interval 1.4 to 12.9	5.6 Months Interval 5.6 to 5.6	4.1 Months Interval 2.7 to 6.7	—	—	—	—

SECONDARY outcome

Timeframe: At screening and Cycle 1 Day 1.

Population: All enrolled participants in Part B who received at least one dose of one of the components of the regimen.

PSA Baseline is defined as the most recent non-missing value prior to dosing.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=18 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Baseline for PSA in Part B Central PSA	3.05 ng/ml Interval 1.8 to 20.1	33.45 ng/ml Interval 0.8 to 2136.0	2.10 ng/ml Interval 0.5 to 11.5	—	—	—	—
Baseline for PSA in Part B Local PSA	3.050 ng/ml Interval 1.8 to 20.57	37.150 ng/ml Interval 0.7 to 1500.0	2.080 ng/ml Interval 0.5 to 12.43	—	—	—	—

SECONDARY outcome

Timeframe: At screening and Cycle 1 Day 1.

PSADT was defined as the natural log of 2 divided by the slope of the linear regression line of the natural log of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=13 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=12 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Baseline for PSA Doubling Time (PSADT) in Part B	1.768 Months Interval -10.04 to 7.73	1.169 Months Interval -78.5 to 11.82	1.615 Months Interval -10.28 to 20.72	—	—	—	—

SECONDARY outcome

Timeframe: At screening and Cycle 1 Day 1.

PSA slope was defined as the slope of the linear regression line of natural log of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=13 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=12 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Baseline for PSA Slope in Part B	0.178 Ratio Interval -0.2 to 0.75	0.205 Ratio Interval -0.31 to 0.73	0.138 Ratio Interval -0.28 to 0.47	—	—	—	—

SECONDARY outcome

Timeframe: At screening and Cycle 1 Day 1.

PSA velocity was defined as the slope of the linear regression line of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=13 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=12 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Baseline for PSA Velocity in Part B	0.558 ng/ml/month Interval -0.87 to 6.67	3.629 ng/ml/month Interval -63.41 to 46.04	0.109 ng/ml/month Interval -1.24 to 0.91	—	—	—	—

SECONDARY outcome

Timeframe: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.

PSADT was defined as the natural log of 2 divided by the slope of the linear regression line of the natural log of PSA against time in month. PSADT at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=13 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=12 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Change in PSADT at Post-Treatment Visit From Baseline in Part B	4.800 Months Interval -31.92 to 44.66	4.243 Months Interval -0.23 to 80.68	8.078 Months Interval -58.53 to 23.27	—	—	—	—

SECONDARY outcome

Timeframe: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.

PSA slope was defined as the slope of the linear regression line of natural log of PSA against time in month. PSA slope at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=13 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=12 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Change in PSA Slope at Post-Treatment Visit From Baseline in Part B	-0.084 Ratio Interval -0.68 to 0.97	-0.067 Ratio Interval -0.38 to 0.7	0.076 Ratio Interval -0.61 to 0.34	—	—	—	—

SECONDARY outcome

Timeframe: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.

PSA velocity was defined as the slope of the linear regression line of PSA against time in month. PSA velocity at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

Outcome measures

Outcome measures
Measure	Cohort All mCRPC Patients n=20 Participants This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=13 Participants Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=12 Participants Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A and 3B Combined This group included mCRPC participants in 7A and 3B, treated at RP2D dose.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Change in PSA Velocity at Post-Treatment Visit From Baseline in Part B	-0.008 ng/ml/month Interval -4.5 to 5.46	8.641 ng/ml/month Interval -9.56 to 473.67	0.185 ng/ml/month Interval -0.58 to 2.3	—	—	—	—

Adverse Events

Cohort 1A: AdC68 4x10^11 VP + pDNA 5 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 1 deaths

Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg

Serious events: 4 serious events

Other events: 14 other events

Deaths: 2 deaths

Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg

Serious events: 7 serious events

Other events: 18 other events

Deaths: 2 deaths

Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg

Serious events: 6 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1A: AdC68 4x10^11 VP + pDNA 5 mg n=3 participants at risk Participants with mCRPC in Cohort 1A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 4x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 1A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg n=4 participants at risk Participants with mCRPC in Cohort 2A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 2A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=6 participants at risk Participants with mCRPC in Cohort 3A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3A entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=8 participants at risk Participants with mCRPC in Cohort 6A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 6A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=14 participants at risk Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg n=3 participants at risk Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 participants at risk Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=18 participants at risk Participants with mCRPC in Cohort 3B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3B entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 participants at risk Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Infections and infestations Arthritis bacterial	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Haematuria	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Colitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Myasthenia gravis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Hypotension	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Ureteric obstruction	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Immune-mediated myocarditis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Myocarditis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Nausea	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Pyrexia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Diverticulitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Sepsis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Troponin I increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Syncope	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.

Other adverse events

Other adverse events
Measure	Cohort 1A: AdC68 4x10^11 VP + pDNA 5 mg n=3 participants at risk Participants with mCRPC in Cohort 1A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 4x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 1A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg n=4 participants at risk Participants with mCRPC in Cohort 2A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 2A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=6 participants at risk Participants with mCRPC in Cohort 3A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3A entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=8 participants at risk Participants with mCRPC in Cohort 6A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 6A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=14 participants at risk Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg n=3 participants at risk Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n=20 participants at risk Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg n=18 participants at risk Participants with mCRPC in Cohort 3B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3B entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n=15 participants at risk Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	62.5% 5/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	28.6% 4/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	77.8% 14/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Tachycardia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Cataract	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Vision blurred	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Constipation	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	42.9% 6/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	37.5% 3/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	35.7% 5/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 5/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	44.4% 8/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	53.3% 8/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Nausea	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 4/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	35.7% 5/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	66.7% 2/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 5/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Tongue disorder	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Asthenia	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Chills	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Fatigue	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 4/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	35.7% 5/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	100.0% 3/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	60.0% 12/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	38.9% 7/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	53.3% 8/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Gait disturbance	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Influenza like illness	66.7% 2/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	42.9% 6/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	60.0% 12/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 5/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Infusion site extravasation	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site discomfort	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site reaction	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Oedema peripheral	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Peripheral swelling	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Pyrexia	66.7% 2/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 4/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Bronchitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Bronchitis bacterial	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Conjunctivitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Cystitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Fungal skin infection	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Gastroenteritis	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Sinusitis	33.3% 1/3 • Number of events 3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Urethritis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Skin abrasion	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Muscle strain	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	37.5% 3/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 5/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Amylase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	37.5% 3/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 6/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 5/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood creatinine increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 4/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood pressure increased	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations C-reactive protein increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Lipase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	21.4% 3/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 5/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 6/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 5/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Red blood cell sedimentation rate increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Weight decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 4/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	28.6% 4/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 6/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	21.4% 3/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 3/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 4/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	42.9% 6/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	66.7% 2/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 8/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 5/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Back pain	66.7% 2/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	21.4% 3/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 5/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 5/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	66.7% 2/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 5/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Dizziness	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Headache	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	30.0% 6/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 6/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Hypersomnia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Anxiety	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	28.6% 4/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Insomnia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Bladder spasm	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Cystitis noninfective	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Dysuria	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Haematuria	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	30.0% 6/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Hydronephrosis	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Nocturia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 3/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Urinary tract pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 3/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 6/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 5/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 2/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Hot flush	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Hypertension	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 1/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Hypotension	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Bradycardia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	26.7% 4/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Endocrine disorders Hypopituitarism	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	26.7% 4/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Dry eye	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 4/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Chronic gastritis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Colitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Defaecation urgency	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Faeces discoloured	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Mucous stools	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	30.0% 6/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Malaise	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Oedema	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Candida infection	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Cellulitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Rash pustular	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	37.5% 3/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	46.7% 7/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood magnesium decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood magnesium increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood phosphorus decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood phosphorus increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood uric acid increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Electrocardiogram abnormal	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Eosinophil count increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Heart rate irregular	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Lymphocyte count decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 6/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Neutrophil count decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Platelet count decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	38.9% 7/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Prothrombin time prolonged	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations White blood cell count decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	26.7% 4/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	38.9% 7/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	38.9% 7/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 2/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	44.4% 8/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 4/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Polydipsia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	21.4% 3/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Amnesia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Aphasia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Disturbance in attention	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Dysgeusia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Facial paralysis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Hemiparesis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Myasthenia gravis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Paraesthesia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Syncope	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Trigeminal nerve disorder	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Reproductive system and breast disorders Breast tenderness	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Depressed mood	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	14.3% 2/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	16.7% 3/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Chronic kidney disease	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Incontinence	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	15.0% 3/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	22.2% 4/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	10.0% 2/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Livedo reticularis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 1/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.0% 1/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Haematoma	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	7.1% 1/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Cardiac failure	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Palpitations	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 3/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Vitreous haemorrhage	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Ascites	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Swollen tongue	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site bruising	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site haematoma	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Pain	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Immune system disorders Seasonal allergy	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Sepsis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Suspected COVID-19	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations International normalised ratio increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	27.8% 5/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations SARS-CoV-2 test positive	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Thyroxine increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Troponin increased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Memory impairment	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Spinal cord compression	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Taste disorder	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Depression	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Micturition urgency	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Capillary leak syndrome	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/7 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	13.3% 2/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	5.6% 1/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/8 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	11.1% 2/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/6 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/7 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/14 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/20 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/18 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.7% 1/15 • Baseline up to 6 months after EOT (52 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.

Additional Information

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Phone: 1-800-718-1021

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER