Trial Outcomes & Findings for Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study (NCT NCT05131477)

NCT ID: NCT05131477

Last Updated: 2025-07-03

Results Overview

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 390 participants
• Primary outcome timeframe: Baseline to week 16
• Results posted on: 2025-07-03

Participant Flow

This study started in December 2021 and ended in February 2024. An individual participant was part of this study for about 1 year and 5 months. The study took place at 100 sites in 12 countries. Up to 350 participants (approximately 70 participants per treatment group) were planned to be enrolled.

The study was performed in 2 parts: Part 1 for all population (baseline to Week 24) for efficacy and safety and Part 2 for Part 1 Responders (Week 24 to Week 52 for efficacy and Week 24 to Week 68 for safety). Responders are defined as participants who achieved ≥EASI 75 and/or IGA 0/1 at Week 24.

Participant milestones

Measure	250 mg (500 mg LD) KY1005 (Part 1) Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	250 mg (no LD) KY1005 (Part 1) Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.	125 mg KY1005 (Part 1) Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.	62.5 mg KY1005 (Part 1) Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.	Placebo (Part 1) Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
PART 1 STARTED	77	78	77	79	79	0	0	0	0	0	0	0	0	0
PART 1 Randomized and Treated	77	78	77	78	78	0	0	0	0	0	0	0	0	0
PART 1 Re-randomized at Week 24	47	40	45	42	16	0	0	0	0	0	0	0	0	0
PART 1 COMPLETED	68	62	69	67	57	0	0	0	0	0	0	0	0	0
PART 1 NOT COMPLETED	9	16	8	12	22	0	0	0	0	0	0	0	0	0
PART 2 STARTED	0	0	0	0	0	13	34	12	28	12	33	7	35	16
PART 2 Re-randomized and Treated	0	0	0	0	0	13	34	11	28	12	32	7	34	15
PART 2 COMPLETED	0	0	0	0	0	12	31	11	24	11	28	7	29	13
PART 2 NOT COMPLETED	0	0	0	0	0	1	3	1	4	1	5	0	6	3

Reasons for withdrawal

Measure	250 mg (500 mg LD) KY1005 (Part 1) Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	250 mg (no LD) KY1005 (Part 1) Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.	125 mg KY1005 (Part 1) Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.	62.5 mg KY1005 (Part 1) Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.	Placebo (Part 1) Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
PART 1 Withdrawal by Subject	2	9	6	2	8	0	0	0	0	0	0	0	0	0
PART 1 Physician Decision	1	0	0	0	0	0	0	0	0	0	0	0	0	0
PART 1 Adverse Event	3	5	1	6	4	0	0	0	0	0	0	0	0	0
PART 1 unclassified	1	1	0	0	4	0	0	0	0	0	0	0	0	0
PART 1 Randomized and not treated	0	0	0	1	1	0	0	0	0	0	0	0	0	0
PART 1 Protocol Violation	2	0	0	1	0	0	0	0	0	0	0	0	0	0
PART 1 Lack of Efficacy	0	1	1	2	5	0	0	0	0	0	0	0	0	0
PART 2 Withdrawal by Subject	0	0	0	0	0	0	2	0	0	0	2	0	2	2
PART 2 Other	0	0	0	0	0	0	0	0	1	1	0	0	1	0
PART 2 Lack of Efficacy	0	0	0	0	0	1	1	0	3	0	1	0	2	0
PART 2 Unclassified	0	0	0	0	0	0	0	0	0	0	1	0	0	0
PART 2 Re-randomized and not treated	0	0	0	0	0	0	0	1	0	0	1	0	1	1

Baseline Characteristics

There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.

Baseline characteristics by cohort

Measure	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	250 mg (No LD) KY1005 (Part 1) n=78 Participants Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.	125 mg KY1005 (Part 1) n=77 Participants Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.	62.5 mg KY1005 (Part 1) n=79 Participants Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	Total n=390 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 13.32 • n=5 Participants	40.8 years STANDARD_DEVIATION 15.24 • n=7 Participants	37.9 years STANDARD_DEVIATION 15.17 • n=5 Participants	37.6 years STANDARD_DEVIATION 14.78 • n=4 Participants	36.4 years STANDARD_DEVIATION 13.07 • n=21 Participants	37.8 years STANDARD_DEVIATION 14.36 • n=8 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	35 Participants n=7 Participants	39 Participants n=5 Participants	37 Participants n=4 Participants	30 Participants n=21 Participants	171 Participants n=8 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	43 Participants n=7 Participants	38 Participants n=5 Participants	42 Participants n=4 Participants	49 Participants n=21 Participants	219 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=4 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=21 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=8 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Race (NIH/OMB) Asian	12 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	12 Participants n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	10 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	14 Participants n=4 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	12 Participants n=21 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	60 Participants n=8 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=4 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=21 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=8 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	2 Participants n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	4 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	4 Participants n=4 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	6 Participants n=21 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	20 Participants n=8 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Race (NIH/OMB) White	61 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	63 Participants n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	63 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	60 Participants n=4 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	60 Participants n=21 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	307 Participants n=8 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=4 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=21 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=8 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	1 Participants n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	0 Participants n=5 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	1 Participants n=4 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	1 Participants n=21 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.	3 Participants n=8 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
EASI Score at Baseline	30.3 units on a scale STANDARD_DEVIATION 11.66 • n=5 Participants	28.7 units on a scale STANDARD_DEVIATION 10.53 • n=7 Participants	30.3 units on a scale STANDARD_DEVIATION 12.43 • n=5 Participants	28.7 units on a scale STANDARD_DEVIATION 10.09 • n=4 Participants	26.4 units on a scale STANDARD_DEVIATION 7.85 • n=21 Participants	28.9 units on a scale STANDARD_DEVIATION 10.65 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline to week 16

Population: Full Analysis Set for Part 1. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Efficacy analyses were based on treatment allocated at randomization. The Primary efficacy endpoint is the percentage of change in EASI from Baseline to Day 113 (Week 16). The primary analysis was conducted on FAS1 after all the randomized patients had reached the Day 169 (Week 24) visit/ early termination. Missing data were imputed by multiple imputation.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)	-29.4 percentage of change Standard Error 4.76	-61.5 percentage of change Standard Error 4.68	-56.8 percentage of change Standard Error 4.59	-51.6 percentage of change Standard Error 4.59	-59.6 percentage of change Standard Error 4.53	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to week 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage change from baseline in EASI at Day 169 (Week 24). Missing data were imputed by multiple imputation.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)	-27.6 percentage of change Standard Error 5.29	-64.4 percentage of change Standard Error 5.17	-52.2 percentage of change Standard Error 5.14	-53.7 percentage of change Standard Error 5.08	-54.4 percentage of change Standard Error 5.09	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to week 16 and week 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with at least 75% reduction from baseline in EASI (EASI 5) at days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) Week 16	11.4 Percentage of participants	40.3 Percentage of participants	38.5 Percentage of participants	42.9 Percentage of participants	40.5 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) Week 24	17.7 Percentage of participants	54.5 Percentage of participants	38.5 Percentage of participants	49.4 Percentage of participants	40.5 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to week 16 and week 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with a response of IGA 0 or 1 and a reduction from baseline of ≥ 2 points at Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.

The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) Week 16	5.1 Percentage of participants	22.1 Percentage of participants	14.1 Percentage of participants	19.5 Percentage of participants	25.3 Percentage of participants	—	—	—	—
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) Week 24	11.4 Percentage of participants	45.5 Percentage of participants	33.3 Percentage of participants	40.3 Percentage of participants	29.1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to week 16 and week 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 a baseline pruritus NRS of ≥ 4 from baseline to Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) Week 16	5.1 Percentage of participants	24.7 Percentage of participants	19.2 Percentage of participants	20.8 Percentage of participants	22.8 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) Week 24	7.6 Percentage of participants	31.2 Percentage of participants	24.4 Percentage of participants	28.6 Percentage of participants	27.8 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported. Participants with missing data were considered as non-responders.

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 26	58.3 Percentage of participants	53.8 Percentage of participants	38.2 Percentage of participants	66.7 Percentage of participants	32.1 Percentage of participants	33.3 Percentage of participants	71.4 Percentage of participants	42.9 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 27	58.3 Percentage of participants	61.5 Percentage of participants	35.3 Percentage of participants	58.3 Percentage of participants	28.6 Percentage of participants	39.4 Percentage of participants	71.4 Percentage of participants	37.1 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 28	58.3 Percentage of participants	61.5 Percentage of participants	35.3 Percentage of participants	66.7 Percentage of participants	35.7 Percentage of participants	42.4 Percentage of participants	57.1 Percentage of participants	37.1 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 29	58.3 Percentage of participants	69.2 Percentage of participants	38.2 Percentage of participants	50.0 Percentage of participants	25.0 Percentage of participants	45.5 Percentage of participants	57.1 Percentage of participants	40.0 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 30	66.7 Percentage of participants	61.5 Percentage of participants	44.1 Percentage of participants	58.3 Percentage of participants	25.0 Percentage of participants	36.4 Percentage of participants	42.9 Percentage of participants	42.9 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 24	58.3 Percentage of participants	53.8 Percentage of participants	41.2 Percentage of participants	75.0 Percentage of participants	35.7 Percentage of participants	45.5 Percentage of participants	71.4 Percentage of participants	45.7 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 25	66.7 Percentage of participants	53.8 Percentage of participants	41.2 Percentage of participants	66.7 Percentage of participants	39.3 Percentage of participants	39.4 Percentage of participants	57.1 Percentage of participants	37.1 Percentage of participants	31.3 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 31	66.7 Percentage of participants	61.5 Percentage of participants	41.2 Percentage of participants	58.3 Percentage of participants	25.0 Percentage of participants	36.4 Percentage of participants	42.9 Percentage of participants	40.0 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 32	75.0 Percentage of participants	61.5 Percentage of participants	47.1 Percentage of participants	50.0 Percentage of participants	25.0 Percentage of participants	42.4 Percentage of participants	71.4 Percentage of participants	40.0 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 33	58.3 Percentage of participants	61.5 Percentage of participants	47.1 Percentage of participants	58.3 Percentage of participants	28.6 Percentage of participants	42.4 Percentage of participants	71.4 Percentage of participants	40.0 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 34	75.0 Percentage of participants	61.5 Percentage of participants	41.2 Percentage of participants	75.0 Percentage of participants	21.4 Percentage of participants	30.3 Percentage of participants	42.9 Percentage of participants	37.1 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 35	66.7 Percentage of participants	61.5 Percentage of participants	41.2 Percentage of participants	66.7 Percentage of participants	21.4 Percentage of participants	39.4 Percentage of participants	71.4 Percentage of participants	34.3 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 36	66.7 Percentage of participants	61.5 Percentage of participants	38.2 Percentage of participants	58.3 Percentage of participants	21.4 Percentage of participants	42.4 Percentage of participants	71.4 Percentage of participants	40.0 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 37	66.7 Percentage of participants	53.8 Percentage of participants	41.2 Percentage of participants	50.0 Percentage of participants	28.6 Percentage of participants	42.4 Percentage of participants	71.4 Percentage of participants	37.1 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 38	58.3 Percentage of participants	53.8 Percentage of participants	35.3 Percentage of participants	50.0 Percentage of participants	25.0 Percentage of participants	42.4 Percentage of participants	71.4 Percentage of participants	31.4 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 39	58.3 Percentage of participants	53.8 Percentage of participants	41.2 Percentage of participants	50.0 Percentage of participants	25.0 Percentage of participants	39.4 Percentage of participants	71.4 Percentage of participants	31.4 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 40	58.3 Percentage of participants	53.8 Percentage of participants	38.2 Percentage of participants	33.3 Percentage of participants	25.0 Percentage of participants	36.4 Percentage of participants	28.6 Percentage of participants	31.4 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 41	66.7 Percentage of participants	61.5 Percentage of participants	35.3 Percentage of participants	41.7 Percentage of participants	28.6 Percentage of participants	39.4 Percentage of participants	57.1 Percentage of participants	34.3 Percentage of participants	31.3 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 42	66.7 Percentage of participants	53.8 Percentage of participants	38.2 Percentage of participants	50.0 Percentage of participants	28.6 Percentage of participants	36.4 Percentage of participants	42.9 Percentage of participants	31.4 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 43	58.3 Percentage of participants	53.8 Percentage of participants	35.3 Percentage of participants	50.0 Percentage of participants	28.6 Percentage of participants	36.4 Percentage of participants	42.9 Percentage of participants	34.3 Percentage of participants	31.3 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 44	75.0 Percentage of participants	61.5 Percentage of participants	38.2 Percentage of participants	41.7 Percentage of participants	21.4 Percentage of participants	39.4 Percentage of participants	42.9 Percentage of participants	37.1 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 45	75.0 Percentage of participants	61.5 Percentage of participants	41.2 Percentage of participants	41.7 Percentage of participants	21.4 Percentage of participants	36.4 Percentage of participants	42.9 Percentage of participants	40.0 Percentage of participants	31.3 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 46	50.0 Percentage of participants	53.8 Percentage of participants	44.1 Percentage of participants	50.0 Percentage of participants	28.6 Percentage of participants	27.3 Percentage of participants	42.9 Percentage of participants	37.1 Percentage of participants	31.3 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 47	58.3 Percentage of participants	46.2 Percentage of participants	38.2 Percentage of participants	33.3 Percentage of participants	28.6 Percentage of participants	30.3 Percentage of participants	42.9 Percentage of participants	45.7 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 48	66.7 Percentage of participants	38.5 Percentage of participants	35.3 Percentage of participants	41.7 Percentage of participants	28.6 Percentage of participants	27.3 Percentage of participants	57.1 Percentage of participants	37.1 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 49	66.7 Percentage of participants	38.5 Percentage of participants	41.2 Percentage of participants	50.0 Percentage of participants	35.7 Percentage of participants	30.3 Percentage of participants	57.1 Percentage of participants	40.0 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 50	66.7 Percentage of participants	38.5 Percentage of participants	35.3 Percentage of participants	50.0 Percentage of participants	32.1 Percentage of participants	24.2 Percentage of participants	57.1 Percentage of participants	37.1 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 51	58.3 Percentage of participants	30.8 Percentage of participants	32.4 Percentage of participants	41.7 Percentage of participants	28.6 Percentage of participants	27.3 Percentage of participants	42.9 Percentage of participants	34.3 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Week 52	66.7 Percentage of participants	46.2 Percentage of participants	29.4 Percentage of participants	41.7 Percentage of participants	25.0 Percentage of participants	27.3 Percentage of participants	57.1 Percentage of participants	40.0 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 2	-3.98 score on a scale Standard Deviation 7.855	-8.49 score on a scale Standard Deviation 10.777	-5.27 score on a scale Standard Deviation 8.485	-6.17 score on a scale Standard Deviation 10.071	-7.51 score on a scale Standard Deviation 8.836	—	—	—	—
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 4	-7.20 score on a scale Standard Deviation 8.510	-11.21 score on a scale Standard Deviation 10.612	-8.38 score on a scale Standard Deviation 9.944	-10.33 score on a scale Standard Deviation 10.861	-10.27 score on a scale Standard Deviation 10.550	—	—	—	—
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 8	-7.64 score on a scale Standard Deviation 10.450	-15.67 score on a scale Standard Deviation 11.872	-11.93 score on a scale Standard Deviation 11.018	-13.77 score on a scale Standard Deviation 12.964	-14.37 score on a scale Standard Deviation 10.054	—	—	—	—
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 12	-8.76 score on a scale Standard Deviation 9.608	-18.49 score on a scale Standard Deviation 12.411	-13.84 score on a scale Standard Deviation 11.121	-16.56 score on a scale Standard Deviation 14.062	-16.46 score on a scale Standard Deviation 11.699	—	—	—	—
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 16	-7.47 score on a scale Standard Deviation 11.338	-19.71 score on a scale Standard Deviation 12.731	-16.31 score on a scale Standard Deviation 12.329	-15.70 score on a scale Standard Deviation 14.226	-17.82 score on a scale Standard Deviation 11.730	—	—	—	—
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 20	-7.91 score on a scale Standard Deviation 11.163	-21.93 score on a scale Standard Deviation 14.283	-16.46 score on a scale Standard Deviation 12.834	-16.98 score on a scale Standard Deviation 15.321	-16.76 score on a scale Standard Deviation 12.590	—	—	—	—
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 24	-7.52 score on a scale Standard Deviation 12.537	-21.92 score on a scale Standard Deviation 14.475	-15.72 score on a scale Standard Deviation 12.977	-16.91 score on a scale Standard Deviation 15.085	-17.09 score on a scale Standard Deviation 13.088	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 2,4, 8,12,16, 20 and 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 16	-28.25 Percentage of change Standard Deviation 41.173	-62.35 Percentage of change Standard Deviation 32.322	-59.98 Percentage of change Standard Deviation 37.444	-52.50 Percentage of change Standard Deviation 40.820	-61.51 Percentage of change Standard Deviation 31.663	—	—	—	—
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 20	-30.32 Percentage of change Standard Deviation 40.486	-67.85 Percentage of change Standard Deviation 33.135	-57.80 Percentage of change Standard Deviation 38.921	-56.29 Percentage of change Standard Deviation 43.103	-57.87 Percentage of change Standard Deviation 38.977	—	—	—	—
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 24	-28.55 Percentage of change Standard Deviation 44.004	-68.01 Percentage of change Standard Deviation 36.052	-55.84 Percentage of change Standard Deviation 40.299	-56.72 Percentage of change Standard Deviation 44.271	-57.37 Percentage of change Standard Deviation 40.225	—	—	—	—
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 2	-15.26 Percentage of change Standard Deviation 34.143	-27.94 Percentage of change Standard Deviation 30.032	-17.75 Percentage of change Standard Deviation 38.988	-19.09 Percentage of change Standard Deviation 39.499	-26.03 Percentage of change Standard Deviation 34.462	—	—	—	—
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 4	-27.56 Percentage of change Standard Deviation 31.037	-36.85 Percentage of change Standard Deviation 28.901	-29.13 Percentage of change Standard Deviation 42.013	-35.10 Percentage of change Standard Deviation 34.457	-35.49 Percentage of change Standard Deviation 38.786	—	—	—	—
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 8	-28.70 Percentage of change Standard Deviation 38.603	-50.25 Percentage of change Standard Deviation 30.666	-41.21 Percentage of change Standard Deviation 41.129	-45.96 Percentage of change Standard Deviation 38.150	-51.70 Percentage of change Standard Deviation 31.046	—	—	—	—
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Week 12	-33.72 Percentage of change Standard Deviation 35.358	-59.61 Percentage of change Standard Deviation 30.717	-50.15 Percentage of change Standard Deviation 36.086	-55.23 Percentage of change Standard Deviation 40.218	-57.36 Percentage of change Standard Deviation 34.275	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 24	-27.10 Score on a scale Standard Deviation 12.670	-29.65 Score on a scale Standard Deviation 11.278	-26.28 Score on a scale Standard Deviation 13.353	-27.60 Score on a scale Standard Deviation 11.170	-18.90 Score on a scale Standard Deviation 11.932	-22.45 Score on a scale Standard Deviation 14.998	-25.47 Score on a scale Standard Deviation 12.209	-22.41 Score on a scale Standard Deviation 12.841	-21.47 Score on a scale Standard Deviation 10.420
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 28	-26.37 Score on a scale Standard Deviation 13.067	-30.51 Score on a scale Standard Deviation 12.422	-26.34 Score on a scale Standard Deviation 14.353	-25.86 Score on a scale Standard Deviation 13.128	-17.29 Score on a scale Standard Deviation 12.458	-22.87 Score on a scale Standard Deviation 15.667	-23.79 Score on a scale Standard Deviation 10.424	-21.75 Score on a scale Standard Deviation 13.106	-21.69 Score on a scale Standard Deviation 11.918
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 32	-27.36 Score on a scale Standard Deviation 13.383	-29.08 Score on a scale Standard Deviation 14.544	-24.79 Score on a scale Standard Deviation 15.775	-22.99 Score on a scale Standard Deviation 15.741	-15.38 Score on a scale Standard Deviation 12.620	-22.94 Score on a scale Standard Deviation 14.915	-24.94 Score on a scale Standard Deviation 11.245	-20.32 Score on a scale Standard Deviation 14.189	-19.60 Score on a scale Standard Deviation 10.632
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 36	-27.51 Score on a scale Standard Deviation 13.550	-28.15 Score on a scale Standard Deviation 15.138	-22.78 Score on a scale Standard Deviation 17.505	-22.27 Score on a scale Standard Deviation 16.368	-14.57 Score on a scale Standard Deviation 13.550	-22.99 Score on a scale Standard Deviation 14.978	-24.65 Score on a scale Standard Deviation 10.801	-20.09 Score on a scale Standard Deviation 15.098	-20.20 Score on a scale Standard Deviation 10.436
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 40	-27.96 Score on a scale Standard Deviation 14.444	-28.54 Score on a scale Standard Deviation 15.203	-22.30 Score on a scale Standard Deviation 17.908	-22.56 Score on a scale Standard Deviation 14.949	-14.81 Score on a scale Standard Deviation 13.178	-20.45 Score on a scale Standard Deviation 16.659	-25.51 Score on a scale Standard Deviation 11.796	-20.80 Score on a scale Standard Deviation 14.601	-20.05 Score on a scale Standard Deviation 10.596
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 44	-27.49 Score on a scale Standard Deviation 14.324	-28.43 Score on a scale Standard Deviation 15.061	-22.23 Score on a scale Standard Deviation 17.487	-23.07 Score on a scale Standard Deviation 15.679	-14.49 Score on a scale Standard Deviation 12.877	-19.76 Score on a scale Standard Deviation 16.561	-22.34 Score on a scale Standard Deviation 11.070	-20.70 Score on a scale Standard Deviation 14.343	-20.43 Score on a scale Standard Deviation 11.007
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 48	-27.72 Score on a scale Standard Deviation 14.882	-22.15 Score on a scale Standard Deviation 14.876	-21.82 Score on a scale Standard Deviation 17.764	-22.24 Score on a scale Standard Deviation 16.312	-13.95 Score on a scale Standard Deviation 13.596	-18.34 Score on a scale Standard Deviation 16.959	-23.88 Score on a scale Standard Deviation 12.517	-19.74 Score on a scale Standard Deviation 15.277	-19.99 Score on a scale Standard Deviation 11.292
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 52	-28.08 Score on a scale Standard Deviation 16.097	-22.03 Score on a scale Standard Deviation 14.889	-19.59 Score on a scale Standard Deviation 15.321	-22.68 Score on a scale Standard Deviation 15.418	-13.89 Score on a scale Standard Deviation 13.427	-17.30 Score on a scale Standard Deviation 16.752	-23.26 Score on a scale Standard Deviation 11.789	-20.81 Score on a scale Standard Deviation 14.813	-20.30 Score on a scale Standard Deviation 11.526

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 24	-90.91 Percentage of change Standard Deviation 10.585	-91.71 Percentage of change Standard Deviation 8.539	-81.85 Percentage of change Standard Deviation 31.624	-84.20 Percentage of change Standard Deviation 16.741	-72.72 Percentage of change Standard Deviation 41.299	-74.56 Percentage of change Standard Deviation 39.811	-85.81 Percentage of change Standard Deviation 10.212	-76.74 Percentage of change Standard Deviation 30.922	-78.51 Percentage of change Standard Deviation 28.977
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 28	-87.78 Percentage of change Standard Deviation 13.648	-93.56 Percentage of change Standard Deviation 8.382	-81.47 Percentage of change Standard Deviation 32.251	-79.34 Percentage of change Standard Deviation 28.091	-66.53 Percentage of change Standard Deviation 43.437	-74.18 Percentage of change Standard Deviation 42.104	-89.88 Percentage of change Standard Deviation 6.304	-74.54 Percentage of change Standard Deviation 31.665	-76.87 Percentage of change Standard Deviation 31.377
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 32	-91.07 Percentage of change Standard Deviation 13.744	-86.08 Percentage of change Standard Deviation 24.896	-76.51 Percentage of change Standard Deviation 38.401	-69.06 Percentage of change Standard Deviation 38.468	-58.78 Percentage of change Standard Deviation 44.767	-75.64 Percentage of change Standard Deviation 41.038	-93.76 Percentage of change Standard Deviation 4.960	-68.09 Percentage of change Standard Deviation 34.850	-71.98 Percentage of change Standard Deviation 33.063
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 36	-91.22 Percentage of change Standard Deviation 13.203	-86.56 Percentage of change Standard Deviation 28.656	-69.33 Percentage of change Standard Deviation 43.838	-66.64 Percentage of change Standard Deviation 39.631	-56.24 Percentage of change Standard Deviation 46.469	-75.77 Percentage of change Standard Deviation 40.984	-93.09 Percentage of change Standard Deviation 6.000	-67.27 Percentage of change Standard Deviation 40.162	-74.93 Percentage of change Standard Deviation 32.664
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 40	-90.68 Percentage of change Standard Deviation 13.737	-84.74 Percentage of change Standard Deviation 28.948	-65.65 Percentage of change Standard Deviation 44.932	-68.31 Percentage of change Standard Deviation 38.024	-57.39 Percentage of change Standard Deviation 47.379	-64.68 Percentage of change Standard Deviation 64.041	-95.55 Percentage of change Standard Deviation 5.011	-70.11 Percentage of change Standard Deviation 37.802	-74.05 Percentage of change Standard Deviation 32.343
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 44	-90.18 Percentage of change Standard Deviation 12.912	-84.46 Percentage of change Standard Deviation 28.757	-66.73 Percentage of change Standard Deviation 44.328	-69.41 Percentage of change Standard Deviation 38.731	-56.30 Percentage of change Standard Deviation 46.700	-62.46 Percentage of change Standard Deviation 63.983	-83.57 Percentage of change Standard Deviation 21.909	-69.98 Percentage of change Standard Deviation 37.145	-72.99 Percentage of change Standard Deviation 33.353
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 48	-90.26 Percentage of change Standard Deviation 12.961	-71.66 Percentage of change Standard Deviation 40.416	-65.18 Percentage of change Standard Deviation 44.327	-66.61 Percentage of change Standard Deviation 39.645	-53.59 Percentage of change Standard Deviation 48.780	-57.47 Percentage of change Standard Deviation 65.142	-88.02 Percentage of change Standard Deviation 22.234	-66.63 Percentage of change Standard Deviation 40.889	-70.92 Percentage of change Standard Deviation 33.888
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Week 52	-89.09 Percentage of change Standard Deviation 15.625	-71.22 Percentage of change Standard Deviation 40.152	-61.78 Percentage of change Standard Deviation 44.406	-68.09 Percentage of change Standard Deviation 37.719	-53.58 Percentage of change Standard Deviation 48.725	-54.42 Percentage of change Standard Deviation 65.177	-86.51 Percentage of change Standard Deviation 22.331	-69.76 Percentage of change Standard Deviation 38.241	-72.04 Percentage of change Standard Deviation 34.827

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participant with missing data were considered as non-responders.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Week 2	13.9 Percentage of participants	19.5 Percentage of participants	15.4 Percentage of participants	16.9 Percentage of participants	22.8 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Week 4	24.1 Percentage of participants	29.9 Percentage of participants	21.8 Percentage of participants	39.0 Percentage of participants	39.2 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Week 8	27.8 Percentage of participants	45.5 Percentage of participants	38.5 Percentage of participants	53.2 Percentage of participants	54.4 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Week 12	26.6 Percentage of participants	62.3 Percentage of participants	44.9 Percentage of participants	61.0 Percentage of participants	62.0 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Week 16	27.8 Percentage of participants	63.6 Percentage of participants	52.6 Percentage of participants	57.1 Percentage of participants	65.8 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Week 20	25.3 Percentage of participants	63.6 Percentage of participants	51.3 Percentage of participants	58.4 Percentage of participants	58.2 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Week 24	24.1 Percentage of participants	66.2 Percentage of participants	43.6 Percentage of participants	55.8 Percentage of participants	53.2 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline at weeks 2, 4, 8, 12, 16, 20 and 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Week 2	5.1 Percentage of participants	9.1 Percentage of participants	2.6 Percentage of participants	2.6 Percentage of participants	2.5 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Week 4	6.3 Percentage of participants	9.1 Percentage of participants	9.0 Percentage of participants	11.7 Percentage of participants	11.4 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Week 8	8.9 Percentage of participants	23.4 Percentage of participants	16.7 Percentage of participants	27.3 Percentage of participants	25.3 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Week 12	11.4 Percentage of participants	33.8 Percentage of participants	25.6 Percentage of participants	44.2 Percentage of participants	43.0 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Week 16	11.4 Percentage of participants	40.3 Percentage of participants	38.5 Percentage of participants	42.9 Percentage of participants	40.5 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Week 20	13.9 Percentage of participants	49.4 Percentage of participants	42.3 Percentage of participants	48.1 Percentage of participants	40.5 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Week 24	17.7 Percentage of participants	54.5 Percentage of participants	38.5 Percentage of participants	49.4 Percentage of participants	40.5 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) Week 2	0 Percentage of participants	2.6 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants	1.3 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) Week 4	0 Percentage of participants	6.5 Percentage of participants	1.3 Percentage of participants	1.3 Percentage of participants	2.5 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) Week 8	1.3 Percentage of participants	7.8 Percentage of participants	7.7 Percentage of participants	9.1 Percentage of participants	8.9 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) Week 12	5.1 Percentage of participants	10.4 Percentage of participants	9.0 Percentage of participants	14.3 Percentage of participants	12.7 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) Week 16	3.8 Percentage of participants	15.6 Percentage of participants	14.1 Percentage of participants	16.9 Percentage of participants	19.0 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) Week 20	7.6 Percentage of participants	27.3 Percentage of participants	23.1 Percentage of participants	24.7 Percentage of participants	19.0 Percentage of participants	—	—	—	—
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) Week 24	11.4 Percentage of participants	37.7 Percentage of participants	26.9 Percentage of participants	32.5 Percentage of participants	24.1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) Week 2	0 Percentage of participants	0 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) Week 4	0 Percentage of participants	2.6 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) Week 8	0 Percentage of participants	2.6 Percentage of participants	5.1 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants	—	—	—	—
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) Week 12	0 Percentage of participants	3.9 Percentage of participants	2.6 Percentage of participants	2.6 Percentage of participants	2.5 Percentage of participants	—	—	—	—
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) Week 16	1.3 Percentage of participants	3.9 Percentage of participants	1.3 Percentage of participants	2.6 Percentage of participants	1.3 Percentage of participants	—	—	—	—
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) Week 20	1.3 Percentage of participants	6.5 Percentage of participants	6.4 Percentage of participants	3.9 Percentage of participants	2.5 Percentage of participants	—	—	—	—
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) Week 24	3.8 Percentage of participants	7.8 Percentage of participants	6.4 Percentage of participants	9.1 Percentage of participants	1.3 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) Week 2	-0.18 Score on a scale Standard Deviation 0.503	-0.33 Score on a scale Standard Deviation 0.625	-0.21 Score on a scale Standard Deviation 0.408	-0.29 Score on a scale Standard Deviation 0.540	-0.23 Score on a scale Standard Deviation 0.481	—	—	—	—
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) Week 4	-0.31 Score on a scale Standard Deviation 0.592	-0.57 Score on a scale Standard Deviation 0.869	-0.38 Score on a scale Standard Deviation 0.590	-0.45 Score on a scale Standard Deviation 0.620	-0.51 Score on a scale Standard Deviation 0.661	—	—	—	—
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) Week 8	-0.32 Score on a scale Standard Deviation 0.728	-0.79 Score on a scale Standard Deviation 0.976	-0.74 Score on a scale Standard Deviation 0.829	-0.80 Score on a scale Standard Deviation 0.900	-0.76 Score on a scale Standard Deviation 0.709	—	—	—	—
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) Week 12	-0.36 Score on a scale Standard Deviation 0.660	-1.10 Score on a scale Standard Deviation 1.024	-0.87 Score on a scale Standard Deviation 0.867	-1.04 Score on a scale Standard Deviation 1.013	-1.00 Score on a scale Standard Deviation 0.973	—	—	—	—
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) Week 16	-0.43 Score on a scale Standard Deviation 0.757	-1.23 Score on a scale Standard Deviation 0.981	-0.99 Score on a scale Standard Deviation 0.899	-0.96 Score on a scale Standard Deviation 1.033	-1.09 Score on a scale Standard Deviation 0.969	—	—	—	—
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) Week 20	-0.45 Score on a scale Standard Deviation 0.822	-1.43 Score on a scale Standard Deviation 1.118	-1.17 Score on a scale Standard Deviation 1.137	-1.11 Score on a scale Standard Deviation 1.120	-1.10 Score on a scale Standard Deviation 0.981	—	—	—	—
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) Week 24	-0.49 Score on a scale Standard Deviation 0.959	-1.48 Score on a scale Standard Deviation 1.205	-1.16 Score on a scale Standard Deviation 1.241	-1.32 Score on a scale Standard Deviation 1.265	-1.16 Score on a scale Standard Deviation 1.030	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.

The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 24	-2.42 Score on a scale Standard Deviation 0.793	-2.31 Score on a scale Standard Deviation 0.855	-1.91 Score on a scale Standard Deviation 1.026	-2.00 Score on a scale Standard Deviation 0.953	-1.82 Score on a scale Standard Deviation 1.156	-1.82 Score on a scale Standard Deviation 1.131	-2.00 Score on a scale Standard Deviation 1.000	-1.73 Score on a scale Standard Deviation 0.911	-1.63 Score on a scale Standard Deviation 1.204
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 28	-2.25 Score on a scale Standard Deviation 0.965	-2.46 Score on a scale Standard Deviation 0.967	-2.00 Score on a scale Standard Deviation 1.155	-2.17 Score on a scale Standard Deviation 1.193	-1.46 Score on a scale Standard Deviation 1.138	-1.74 Score on a scale Standard Deviation 1.064	-1.71 Score on a scale Standard Deviation 0.951	-1.47 Score on a scale Standard Deviation 0.961	-1.71 Score on a scale Standard Deviation 1.383
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 32	-2.33 Score on a scale Standard Deviation 0.985	-2.00 Score on a scale Standard Deviation 1.000	-1.82 Score on a scale Standard Deviation 1.314	-1.73 Score on a scale Standard Deviation 1.348	-1.32 Score on a scale Standard Deviation 1.188	-1.75 Score on a scale Standard Deviation 1.078	-1.71 Score on a scale Standard Deviation 0.951	-1.41 Score on a scale Standard Deviation 1.160	-1.67 Score on a scale Standard Deviation 1.234
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 36	-2.17 Score on a scale Standard Deviation 1.115	-2.08 Score on a scale Standard Deviation 1.188	-1.70 Score on a scale Standard Deviation 1.380	-1.40 Score on a scale Standard Deviation 1.174	-1.29 Score on a scale Standard Deviation 1.182	-1.81 Score on a scale Standard Deviation 1.230	-2.00 Score on a scale Standard Deviation 1.000	-1.53 Score on a scale Standard Deviation 1.344	-1.67 Score on a scale Standard Deviation 1.234
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 40	-2.36 Score on a scale Standard Deviation 1.120	-2.08 Score on a scale Standard Deviation 1.115	-1.71 Score on a scale Standard Deviation 1.395	-1.64 Score on a scale Standard Deviation 1.286	-1.29 Score on a scale Standard Deviation 1.301	-1.75 Score on a scale Standard Deviation 1.164	-1.86 Score on a scale Standard Deviation 1.215	-1.58 Score on a scale Standard Deviation 1.311	-1.53 Score on a scale Standard Deviation 1.302
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 44	-2.08 Score on a scale Standard Deviation 1.084	-2.00 Score on a scale Standard Deviation 1.155	-1.69 Score on a scale Standard Deviation 1.447	-1.73 Score on a scale Standard Deviation 1.348	-1.32 Score on a scale Standard Deviation 1.335	-1.63 Score on a scale Standard Deviation 1.070	-1.71 Score on a scale Standard Deviation 1.113	-1.58 Score on a scale Standard Deviation 1.259	-1.64 Score on a scale Standard Deviation 1.393
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 48	-2.08 Score on a scale Standard Deviation 1.240	-1.69 Score on a scale Standard Deviation 1.182	-1.69 Score on a scale Standard Deviation 1.469	-1.60 Score on a scale Standard Deviation 1.350	-1.36 Score on a scale Standard Deviation 1.367	-1.50 Score on a scale Standard Deviation 1.137	-2.00 Score on a scale Standard Deviation 1.414	-1.63 Score on a scale Standard Deviation 1.351	-1.71 Score on a scale Standard Deviation 1.590
Change in IGA (Investigator Global Assessment) From Baseline (Part 2) Week 52	-2.18 Score on a scale Standard Deviation 1.401	-1.77 Score on a scale Standard Deviation 1.301	-1.55 Score on a scale Standard Deviation 1.434	-1.64 Score on a scale Standard Deviation 1.286	-1.36 Score on a scale Standard Deviation 1.420	-1.48 Score on a scale Standard Deviation 1.214	-2.00 Score on a scale Standard Deviation 1.155	-1.65 Score on a scale Standard Deviation 1.305	-1.79 Score on a scale Standard Deviation 1.672

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8,12,16,20 & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.

The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) Week 2	1.3 Percentage of participants	1.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) Week 4	2.5 Percentage of participants	5.2 Percentage of participants	1.3 Percentage of participants	1.3 Percentage of participants	2.5 Percentage of participants	—	—	—	—
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) Week 8	5.1 Percentage of participants	9.1 Percentage of participants	9.0 Percentage of participants	13.0 Percentage of participants	5.1 Percentage of participants	—	—	—	—
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) Week 12	3.8 Percentage of participants	16.9 Percentage of participants	12.8 Percentage of participants	19.5 Percentage of participants	19.0 Percentage of participants	—	—	—	—
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) Week 16	5.1 Percentage of participants	22.1 Percentage of participants	14.1 Percentage of participants	19.5 Percentage of participants	25.3 Percentage of participants	—	—	—	—
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) Week 20	8.9 Percentage of participants	33.8 Percentage of participants	25.6 Percentage of participants	27.3 Percentage of participants	21.5 Percentage of participants	—	—	—	—
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) Week 24	11.4 Percentage of participants	45.5 Percentage of participants	33.3 Percentage of participants	40.3 Percentage of participants	29.1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 4, 8, 12, 16, 20 & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 4	-11.13 Score on a scale Standard Deviation 14.243	-15.30 Score on a scale Standard Deviation 16.517	-12.27 Score on a scale Standard Deviation 13.455	-15.89 Score on a scale Standard Deviation 14.865	-14.43 Score on a scale Standard Deviation 13.691	—	—	—	—
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 8	-12.50 Score on a scale Standard Deviation 16.584	-22.39 Score on a scale Standard Deviation 19.368	-19.61 Score on a scale Standard Deviation 17.527	-21.49 Score on a scale Standard Deviation 19.200	-21.42 Score on a scale Standard Deviation 16.956	—	—	—	—
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 12	-13.97 Score on a scale Standard Deviation 16.898	-27.80 Score on a scale Standard Deviation 19.621	-22.31 Score on a scale Standard Deviation 17.936	-27.72 Score on a scale Standard Deviation 20.084	-26.45 Score on a scale Standard Deviation 19.649	—	—	—	—
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 16	-13.85 Score on a scale Standard Deviation 18.123	-30.12 Score on a scale Standard Deviation 20.086	-25.07 Score on a scale Standard Deviation 20.233	-26.28 Score on a scale Standard Deviation 21.258	-28.15 Score on a scale Standard Deviation 19.831	—	—	—	—
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 20	-13.91 Score on a scale Standard Deviation 19.325	-34.89 Score on a scale Standard Deviation 22.369	-28.04 Score on a scale Standard Deviation 22.472	-29.80 Score on a scale Standard Deviation 23.594	-26.71 Score on a scale Standard Deviation 21.056	—	—	—	—
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 24	-15.08 Score on a scale Standard Deviation 22.739	-36.19 Score on a scale Standard Deviation 24.605	-27.28 Score on a scale Standard Deviation 22.937	-29.96 Score on a scale Standard Deviation 25.735	-28.48 Score on a scale Standard Deviation 21.793	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24.

SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 24	-49.87 Score on a scale Standard Deviation 13.012	-52.22 Score on a scale Standard Deviation 14.314	-44.25 Score on a scale Standard Deviation 21.373	-42.44 Score on a scale Standard Deviation 21.879	-36.77 Score on a scale Standard Deviation 21.919	-41.65 Score on a scale Standard Deviation 24.173	-45.20 Score on a scale Standard Deviation 18.017	-38.45 Score on a scale Standard Deviation 22.077	-40.54 Score on a scale Standard Deviation 23.584
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 28	-47.15 Score on a scale Standard Deviation 16.401	-54.19 Score on a scale Standard Deviation 18.525	-44.30 Score on a scale Standard Deviation 23.737	-43.38 Score on a scale Standard Deviation 24.261	-33.40 Score on a scale Standard Deviation 23.845	-43.95 Score on a scale Standard Deviation 24.475	-41.17 Score on a scale Standard Deviation 19.190	-37.46 Score on a scale Standard Deviation 23.843	-42.98 Score on a scale Standard Deviation 24.770
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 32	-50.76 Score on a scale Standard Deviation 16.285	-51.19 Score on a scale Standard Deviation 23.086	-41.55 Score on a scale Standard Deviation 25.962	-37.58 Score on a scale Standard Deviation 27.000	-28.31 Score on a scale Standard Deviation 23.318	-44.04 Score on a scale Standard Deviation 22.541	-40.76 Score on a scale Standard Deviation 17.685	-36.72 Score on a scale Standard Deviation 25.421	-37.81 Score on a scale Standard Deviation 25.964
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 36	-52.12 Score on a scale Standard Deviation 19.167	-49.68 Score on a scale Standard Deviation 25.709	-38.72 Score on a scale Standard Deviation 27.164	-33.91 Score on a scale Standard Deviation 26.686	-27.91 Score on a scale Standard Deviation 24.154	-45.28 Score on a scale Standard Deviation 23.438	-40.09 Score on a scale Standard Deviation 16.767	-37.15 Score on a scale Standard Deviation 27.483	-39.35 Score on a scale Standard Deviation 25.340
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 40	-52.42 Score on a scale Standard Deviation 19.560	-49.88 Score on a scale Standard Deviation 26.342	-38.96 Score on a scale Standard Deviation 29.090	-36.05 Score on a scale Standard Deviation 27.550	-30.05 Score on a scale Standard Deviation 26.602	-42.93 Score on a scale Standard Deviation 24.694	-45.31 Score on a scale Standard Deviation 22.710	-37.75 Score on a scale Standard Deviation 27.127	-36.74 Score on a scale Standard Deviation 25.865
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 44	-51.14 Score on a scale Standard Deviation 20.299	-47.38 Score on a scale Standard Deviation 26.194	-38.61 Score on a scale Standard Deviation 28.602	-37.95 Score on a scale Standard Deviation 28.362	-29.98 Score on a scale Standard Deviation 26.387	-40.96 Score on a scale Standard Deviation 24.470	-36.39 Score on a scale Standard Deviation 21.651	-36.83 Score on a scale Standard Deviation 27.061	-37.47 Score on a scale Standard Deviation 27.887
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 48	-52.40 Score on a scale Standard Deviation 22.250	-39.75 Score on a scale Standard Deviation 25.447	-38.18 Score on a scale Standard Deviation 29.948	-35.13 Score on a scale Standard Deviation 27.409	-29.71 Score on a scale Standard Deviation 28.021	-38.38 Score on a scale Standard Deviation 24.940	-43.80 Score on a scale Standard Deviation 27.380	-37.64 Score on a scale Standard Deviation 28.543	-38.10 Score on a scale Standard Deviation 28.181
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 52	-50.26 Score on a scale Standard Deviation 26.772	-40.26 Score on a scale Standard Deviation 26.751	-34.69 Score on a scale Standard Deviation 28.925	-35.04 Score on a scale Standard Deviation 27.120	-29.26 Score on a scale Standard Deviation 27.488	-37.07 Score on a scale Standard Deviation 25.763	-42.26 Score on a scale Standard Deviation 25.861	-38.41 Score on a scale Standard Deviation 26.915	-39.94 Score on a scale Standard Deviation 29.182

SECONDARY outcome

Timeframe: Baseline to weeks 4, 8, 12, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.

SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 4	-16.67 Percentage of change Standard Deviation 21.045	-22.02 Percentage of change Standard Deviation 22.050	-18.52 Percentage of change Standard Deviation 20.315	-22.76 Percentage of change Standard Deviation 20.903	-21.42 Percentage of change Standard Deviation 21.101	—	—	—	—
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 8	-18.27 Percentage of change Standard Deviation 23.875	-31.84 Percentage of change Standard Deviation 24.549	-30.00 Percentage of change Standard Deviation 28.050	-30.47 Percentage of change Standard Deviation 26.260	-32.07 Percentage of change Standard Deviation 23.600	—	—	—	—
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 12	-20.70 Percentage of change Standard Deviation 24.587	-40.32 Percentage of change Standard Deviation 25.145	-33.64 Percentage of change Standard Deviation 26.502	-39.38 Percentage of change Standard Deviation 27.228	-39.22 Percentage of change Standard Deviation 26.807	—	—	—	—
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 16	-20.87 Percentage of change Standard Deviation 26.791	-43.25 Percentage of change Standard Deviation 26.555	-37.18 Percentage of change Standard Deviation 28.395	-37.33 Percentage of change Standard Deviation 29.071	-41.44 Percentage of change Standard Deviation 26.134	—	—	—	—
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 20	-20.88 Percentage of change Standard Deviation 28.527	-49.92 Percentage of change Standard Deviation 28.279	-42.07 Percentage of change Standard Deviation 32.179	-42.30 Percentage of change Standard Deviation 32.422	-39.05 Percentage of change Standard Deviation 28.347	—	—	—	—
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) Week 24	-22.21 Percentage of change Standard Deviation 33.233	-57.87 Percentage of change Standard Deviation 32.609	-41.04 Percentage of change Standard Deviation 34.212	-42.58 Percentage of change Standard Deviation 35.812	-41.49 Percentage of change Standard Deviation 29.263	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.

SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 24	-72.55 Percentage of change Standard Deviation 15.422	-76.47 Percentage of change Standard Deviation 11.581	-63.86 Percentage of change Standard Deviation 27.005	-60.09 Percentage of change Standard Deviation 26.373	-57.73 Percentage of change Standard Deviation 34.302	-58.96 Percentage of change Standard Deviation 31.260	-66.12 Percentage of change Standard Deviation 19.532	-55.75 Percentage of change Standard Deviation 26.945	-60.13 Percentage of change Standard Deviation 33.848
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 28	-68.39 Percentage of change Standard Deviation 21.143	-78.39 Percentage of change Standard Deviation 16.236	-63.35 Percentage of change Standard Deviation 28.625	-62.58 Percentage of change Standard Deviation 32.229	-52.12 Percentage of change Standard Deviation 35.950	-61.69 Percentage of change Standard Deviation 32.214	-64.22 Percentage of change Standard Deviation 18.649	-53.98 Percentage of change Standard Deviation 29.707	-62.81 Percentage of change Standard Deviation 36.300
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 32	-74.03 Percentage of change Standard Deviation 21.589	-72.44 Percentage of change Standard Deviation 25.786	-59.37 Percentage of change Standard Deviation 33.889	-53.42 Percentage of change Standard Deviation 34.955	-44.49 Percentage of change Standard Deviation 35.890	-62.38 Percentage of change Standard Deviation 31.104	-64.07 Percentage of change Standard Deviation 16.853	-52.47 Percentage of change Standard Deviation 31.788	-56.11 Percentage of change Standard Deviation 38.003
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 36	-75.08 Percentage of change Standard Deviation 21.563	-71.50 Percentage of change Standard Deviation 31.364	-55.13 Percentage of change Standard Deviation 35.598	-49.88 Percentage of change Standard Deviation 36.111	-43.78 Percentage of change Standard Deviation 36.278	-63.79 Percentage of change Standard Deviation 31.710	-64.24 Percentage of change Standard Deviation 20.730	-53.95 Percentage of change Standard Deviation 35.053	-58.72 Percentage of change Standard Deviation 36.827
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 40	-74.34 Percentage of change Standard Deviation 22.474	-71.43 Percentage of change Standard Deviation 31.643	-54.79 Percentage of change Standard Deviation 38.533	-51.85 Percentage of change Standard Deviation 37.053	-46.81 Percentage of change Standard Deviation 39.055	-61.12 Percentage of change Standard Deviation 34.217	-70.27 Percentage of change Standard Deviation 22.037	-54.56 Percentage of change Standard Deviation 34.785	-54.24 Percentage of change Standard Deviation 36.614
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 44	-73.34 Percentage of change Standard Deviation 22.409	-67.26 Percentage of change Standard Deviation 31.749	-54.96 Percentage of change Standard Deviation 38.272	-54.10 Percentage of change Standard Deviation 37.251	-46.95 Percentage of change Standard Deviation 39.736	-57.94 Percentage of change Standard Deviation 33.953	-58.19 Percentage of change Standard Deviation 33.365	-52.89 Percentage of change Standard Deviation 34.032	-55.26 Percentage of change Standard Deviation 39.204
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 48	-74.37 Percentage of change Standard Deviation 23.066	-59.99 Percentage of change Standard Deviation 35.979	-53.71 Percentage of change Standard Deviation 39.548	-51.66 Percentage of change Standard Deviation 37.347	-45.48 Percentage of change Standard Deviation 41.426	-54.55 Percentage of change Standard Deviation 34.719	-67.92 Percentage of change Standard Deviation 35.766	-54.29 Percentage of change Standard Deviation 35.851	-56.30 Percentage of change Standard Deviation 39.696
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) Week 52	-69.62 Percentage of change Standard Deviation 29.104	-60.41 Percentage of change Standard Deviation 36.686	-49.90 Percentage of change Standard Deviation 40.104	-49.68 Percentage of change Standard Deviation 35.129	-44.93 Percentage of change Standard Deviation 40.527	-52.47 Percentage of change Standard Deviation 35.396	-65.97 Percentage of change Standard Deviation 34.709	-56.19 Percentage of change Standard Deviation 34.460	-58.86 Percentage of change Standard Deviation 40.701

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) Week 2	-4.84 Percentage of body surface area Standard Deviation 9.113	-4.50 Percentage of body surface area Standard Deviation 10.610	-5.61 Percentage of body surface area Standard Deviation 10.165	-9.08 Percentage of body surface area Standard Deviation 15.999	-7.41 Percentage of body surface area Standard Deviation 12.588	—	—	—	—
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) Week 4	-9.67 Percentage of body surface area Standard Deviation 16.941	-12.83 Percentage of body surface area Standard Deviation 15.922	-10.16 Percentage of body surface area Standard Deviation 12.917	-13.34 Percentage of body surface area Standard Deviation 17.347	-12.51 Percentage of body surface area Standard Deviation 16.318	—	—	—	—
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) Week 8	-10.00 Percentage of body surface area Standard Deviation 17.375	-19.37 Percentage of body surface area Standard Deviation 18.857	-15.77 Percentage of body surface area Standard Deviation 17.004	-17.55 Percentage of body surface area Standard Deviation 21.064	-19.11 Percentage of body surface area Standard Deviation 18.253	—	—	—	—
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) Week 12	-11.46 Percentage of body surface area Standard Deviation 17.035	-24.13 Percentage of body surface area Standard Deviation 18.097	-19.54 Percentage of body surface area Standard Deviation 19.578	-21.94 Percentage of body surface area Standard Deviation 22.715	-24.14 Percentage of body surface area Standard Deviation 19.903	—	—	—	—
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) Week 16	-8.87 Percentage of body surface area Standard Deviation 16.956	-26.91 Percentage of body surface area Standard Deviation 20.286	-22.71 Percentage of body surface area Standard Deviation 21.966	-21.74 Percentage of body surface area Standard Deviation 24.799	-26.04 Percentage of body surface area Standard Deviation 20.403	—	—	—	—
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) Week 20	-11.04 Percentage of body surface area Standard Deviation 19.653	-30.25 Percentage of body surface area Standard Deviation 21.850	-23.33 Percentage of body surface area Standard Deviation 22.600	-24.35 Percentage of body surface area Standard Deviation 26.238	-24.63 Percentage of body surface area Standard Deviation 21.263	—	—	—	—
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) Week 24	-10.45 Percentage of body surface area Standard Deviation 20.837	-31.35 Percentage of body surface area Standard Deviation 22.434	-21.82 Percentage of body surface area Standard Deviation 21.882	-22.66 Percentage of body surface area Standard Deviation 27.317	-25.77 Percentage of body surface area Standard Deviation 22.085	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Affected BSA From Baseline (Part 2) Week 24	-41.17 Percentage of body surface area Standard Deviation 22.982	-46.92 Percentage of body surface area Standard Deviation 22.009	-37.94 Percentage of body surface area Standard Deviation 18.723	-37.17 Percentage of body surface area Standard Deviation 17.994	-28.14 Percentage of body surface area Standard Deviation 21.790	-33.81 Percentage of body surface area Standard Deviation 26.454	-40.60 Percentage of body surface area Standard Deviation 26.006	-34.30 Percentage of body surface area Standard Deviation 19.787	-32.06 Percentage of body surface area Standard Deviation 22.831
Absolute Change in Affected BSA From Baseline (Part 2) Week 28	-40.00 Percentage of body surface area Standard Deviation 23.394	-48.69 Percentage of body surface area Standard Deviation 23.329	-38.68 Percentage of body surface area Standard Deviation 20.582	-35.92 Percentage of body surface area Standard Deviation 20.804	-25.54 Percentage of body surface area Standard Deviation 22.718	-35.61 Percentage of body surface area Standard Deviation 25.720	-37.14 Percentage of body surface area Standard Deviation 23.801	-33.62 Percentage of body surface area Standard Deviation 19.692	-36.00 Percentage of body surface area Standard Deviation 24.553
Absolute Change in Affected BSA From Baseline (Part 2) Week 32	-42.08 Percentage of body surface area Standard Deviation 22.685	-47.15 Percentage of body surface area Standard Deviation 25.271	-36.62 Percentage of body surface area Standard Deviation 23.049	-29.64 Percentage of body surface area Standard Deviation 25.590	-23.21 Percentage of body surface area Standard Deviation 23.710	-35.94 Percentage of body surface area Standard Deviation 26.193	-38.00 Percentage of body surface area Standard Deviation 23.847	-32.13 Percentage of body surface area Standard Deviation 21.515	-30.07 Percentage of body surface area Standard Deviation 22.861
Absolute Change in Affected BSA From Baseline (Part 2) Week 36	-41.67 Percentage of body surface area Standard Deviation 23.051	-46.00 Percentage of body surface area Standard Deviation 26.242	-33.61 Percentage of body surface area Standard Deviation 24.187	-28.30 Percentage of body surface area Standard Deviation 26.437	-22.21 Percentage of body surface area Standard Deviation 23.857	-35.75 Percentage of body surface area Standard Deviation 25.664	-37.86 Percentage of body surface area Standard Deviation 24.674	-30.91 Percentage of body surface area Standard Deviation 24.288	-31.27 Percentage of body surface area Standard Deviation 24.391
Absolute Change in Affected BSA From Baseline (Part 2) Week 40	-41.45 Percentage of body surface area Standard Deviation 23.729	-46.62 Percentage of body surface area Standard Deviation 26.314	-32.94 Percentage of body surface area Standard Deviation 24.589	-29.18 Percentage of body surface area Standard Deviation 24.774	-22.57 Percentage of body surface area Standard Deviation 23.841	-33.41 Percentage of body surface area Standard Deviation 22.649	-39.57 Percentage of body surface area Standard Deviation 24.758	-32.00 Percentage of body surface area Standard Deviation 23.697	-31.27 Percentage of body surface area Standard Deviation 24.566
Absolute Change in Affected BSA From Baseline (Part 2) Week 44	-42.17 Percentage of body surface area Standard Deviation 25.283	-47.23 Percentage of body surface area Standard Deviation 26.540	-33.22 Percentage of body surface area Standard Deviation 24.143	-29.73 Percentage of body surface area Standard Deviation 25.503	-22.21 Percentage of body surface area Standard Deviation 23.706	-31.91 Percentage of body surface area Standard Deviation 22.069	-34.43 Percentage of body surface area Standard Deviation 25.172	-32.23 Percentage of body surface area Standard Deviation 23.250	-27.43 Percentage of body surface area Standard Deviation 20.478
Absolute Change in Affected BSA From Baseline (Part 2) Week 48	-42.92 Percentage of body surface area Standard Deviation 25.336	-35.69 Percentage of body surface area Standard Deviation 26.183	-32.72 Percentage of body surface area Standard Deviation 25.358	-28.30 Percentage of body surface area Standard Deviation 26.378	-21.50 Percentage of body surface area Standard Deviation 24.053	-30.53 Percentage of body surface area Standard Deviation 23.544	-36.43 Percentage of body surface area Standard Deviation 21.141	-31.13 Percentage of body surface area Standard Deviation 26.208	-26.93 Percentage of body surface area Standard Deviation 20.775
Absolute Change in Affected BSA From Baseline (Part 2) Week 52	-45.09 Percentage of body surface area Standard Deviation 25.770	-35.54 Percentage of body surface area Standard Deviation 26.384	-29.48 Percentage of body surface area Standard Deviation 22.232	-29.55 Percentage of body surface area Standard Deviation 25.359	-21.46 Percentage of body surface area Standard Deviation 23.562	-29.66 Percentage of body surface area Standard Deviation 23.818	-34.71 Percentage of body surface area Standard Deviation 18.688	-33.33 Percentage of body surface area Standard Deviation 22.702	-27.21 Percentage of body surface area Standard Deviation 20.955

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Affected BSA From Baseline (Part 1) Week 2	-11.45 Percentage change Standard Deviation 22.767	-10.11 Percentage change Standard Deviation 24.013	-12.23 Percentage change Standard Deviation 26.053	-19.43 Percentage change Standard Deviation 30.139	-15.06 Percentage change Standard Deviation 37.312	—	—	—	—
Percentage Change in Affected BSA From Baseline (Part 1) Week 4	-20.92 Percentage change Standard Deviation 38.260	-26.45 Percentage change Standard Deviation 28.733	-23.44 Percentage change Standard Deviation 28.941	-29.46 Percentage change Standard Deviation 32.934	-28.84 Percentage change Standard Deviation 38.412	—	—	—	—
Percentage Change in Affected BSA From Baseline (Part 1) Week 8	-21.24 Percentage change Standard Deviation 40.914	-39.12 Percentage change Standard Deviation 31.915	-36.01 Percentage change Standard Deviation 35.268	-37.60 Percentage change Standard Deviation 36.988	-42.84 Percentage change Standard Deviation 33.931	—	—	—	—
Percentage Change in Affected BSA From Baseline (Part 1) Week 12	-26.56 Percentage change Standard Deviation 36.705	-49.88 Percentage change Standard Deviation 29.737	-43.68 Percentage change Standard Deviation 38.140	-47.04 Percentage change Standard Deviation 40.519	-52.16 Percentage change Standard Deviation 35.736	—	—	—	—
Percentage Change in Affected BSA From Baseline (Part 1) Week 16	-22.37 Percentage change Standard Deviation 40.483	-54.58 Percentage change Standard Deviation 32.206	-49.44 Percentage change Standard Deviation 40.861	-46.35 Percentage change Standard Deviation 43.511	-56.36 Percentage change Standard Deviation 35.593	—	—	—	—
Percentage Change in Affected BSA From Baseline (Part 1) Week 20	-25.46 Percentage change Standard Deviation 42.034	-59.75 Percentage change Standard Deviation 33.804	-51.07 Percentage change Standard Deviation 42.023	-50.36 Percentage change Standard Deviation 45.871	-53.55 Percentage change Standard Deviation 42.762	—	—	—	—
Percentage Change in Affected BSA From Baseline (Part 1) Week 24	-23.76 Percentage change Standard Deviation 44.394	-63.02 Percentage change Standard Deviation 36.184	-49.42 Percentage change Standard Deviation 43.012	-48.11 Percentage change Standard Deviation 48.748	-52.94 Percentage change Standard Deviation 44.872	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Affected BSA From Baseline (Part 2) Week 24	-85.29 Percentage change Standard Deviation 19.008	-88.09 Percentage change Standard Deviation 12.983	-78.75 Percentage change Standard Deviation 27.966	-80.67 Percentage change Standard Deviation 27.843	-67.85 Percentage change Standard Deviation 39.902	-71.05 Percentage change Standard Deviation 39.900	-80.52 Percentage change Standard Deviation 14.717	-74.02 Percentage change Standard Deviation 31.419	-72.91 Percentage change Standard Deviation 34.317
Percentage Change in Affected BSA From Baseline (Part 2) Week 28	-81.75 Percentage change Standard Deviation 24.996	-90.51 Percentage change Standard Deviation 10.816	-79.51 Percentage change Standard Deviation 29.501	-76.55 Percentage change Standard Deviation 35.680	-62.09 Percentage change Standard Deviation 42.748	-73.28 Percentage change Standard Deviation 40.454	-88.57 Percentage change Standard Deviation 5.800	-72.98 Percentage change Standard Deviation 30.947	-75.14 Percentage change Standard Deviation 37.955
Percentage Change in Affected BSA From Baseline (Part 2) Week 32	-86.34 Percentage change Standard Deviation 18.724	-83.58 Percentage change Standard Deviation 23.940	-75.09 Percentage change Standard Deviation 36.907	-65.07 Percentage change Standard Deviation 49.743	-55.89 Percentage change Standard Deviation 45.768	-74.61 Percentage change Standard Deviation 40.429	-90.31 Percentage change Standard Deviation 10.263	-66.90 Percentage change Standard Deviation 35.357	-69.74 Percentage change Standard Deviation 38.644
Percentage Change in Affected BSA From Baseline (Part 2) Week 36	-85.33 Percentage change Standard Deviation 18.348	-81.56 Percentage change Standard Deviation 27.924	-68.81 Percentage change Standard Deviation 40.261	-61.93 Percentage change Standard Deviation 51.222	-53.48 Percentage change Standard Deviation 45.933	-74.73 Percentage change Standard Deviation 40.570	-89.70 Percentage change Standard Deviation 10.552	-63.85 Percentage change Standard Deviation 46.152	-72.34 Percentage change Standard Deviation 39.621
Percentage Change in Affected BSA From Baseline (Part 2) Week 40	-86.81 Percentage change Standard Deviation 17.237	-82.62 Percentage change Standard Deviation 28.019	-66.33 Percentage change Standard Deviation 41.876	-64.54 Percentage change Standard Deviation 49.422	-54.92 Percentage change Standard Deviation 47.035	-72.10 Percentage change Standard Deviation 41.016	-94.09 Percentage change Standard Deviation 5.083	-66.00 Percentage change Standard Deviation 43.207	-72.08 Percentage change Standard Deviation 39.691
Percentage Change in Affected BSA From Baseline (Part 2) Week 44	-84.47 Percentage change Standard Deviation 24.104	-83.52 Percentage change Standard Deviation 28.118	-66.91 Percentage change Standard Deviation 41.122	-65.39 Percentage change Standard Deviation 49.945	-53.82 Percentage change Standard Deviation 46.414	-69.38 Percentage change Standard Deviation 41.133	-81.11 Percentage change Standard Deviation 19.107	-66.54 Percentage change Standard Deviation 41.241	-70.30 Percentage change Standard Deviation 40.560
Percentage Change in Affected BSA From Baseline (Part 2) Week 48	-85.70 Percentage change Standard Deviation 19.040	-69.37 Percentage change Standard Deviation 40.195	-64.74 Percentage change Standard Deviation 42.092	-62.01 Percentage change Standard Deviation 51.359	-52.52 Percentage change Standard Deviation 47.479	-64.73 Percentage change Standard Deviation 42.700	-87.79 Percentage change Standard Deviation 16.209	-62.58 Percentage change Standard Deviation 48.827	-68.01 Percentage change Standard Deviation 40.428
Percentage Change in Affected BSA From Baseline (Part 2) Week 52	-89.06 Percentage change Standard Deviation 14.176	-68.90 Percentage change Standard Deviation 40.301	-61.59 Percentage change Standard Deviation 42.339	-64.90 Percentage change Standard Deviation 49.605	-52.82 Percentage change Standard Deviation 47.733	-62.25 Percentage change Standard Deviation 42.451	-85.46 Percentage change Standard Deviation 16.921	-68.75 Percentage change Standard Deviation 39.935	-68.78 Percentage change Standard Deviation 41.236

SECONDARY outcome

Timeframe: Baseline to weeks 4, 8, 12, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 4	-2.32 Score on a scale Standard Deviation 5.910	-4.40 Score on a scale Standard Deviation 6.403	-4.01 Score on a scale Standard Deviation 6.287	-5.42 Score on a scale Standard Deviation 6.498	-4.08 Score on a scale Standard Deviation 5.448	—	—	—	—
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 8	-2.13 Score on a scale Standard Deviation 6.400	-7.03 Score on a scale Standard Deviation 6.869	-5.13 Score on a scale Standard Deviation 7.093	-5.70 Score on a scale Standard Deviation 6.943	-6.75 Score on a scale Standard Deviation 6.646	—	—	—	—
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 12	-2.26 Score on a scale Standard Deviation 6.088	-7.87 Score on a scale Standard Deviation 7.286	-6.50 Score on a scale Standard Deviation 7.229	-7.29 Score on a scale Standard Deviation 7.216	-7.36 Score on a scale Standard Deviation 7.460	—	—	—	—
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 16	-2.37 Score on a scale Standard Deviation 6.867	-8.28 Score on a scale Standard Deviation 7.286	-7.23 Score on a scale Standard Deviation 7.744	-7.19 Score on a scale Standard Deviation 7.720	-7.32 Score on a scale Standard Deviation 7.017	—	—	—	—
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 20	-2.33 Score on a scale Standard Deviation 6.821	-9.39 Score on a scale Standard Deviation 7.577	-7.13 Score on a scale Standard Deviation 8.662	-8.10 Score on a scale Standard Deviation 8.150	-7.39 Score on a scale Standard Deviation 7.721	—	—	—	—
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 24	-2.19 Score on a scale Standard Deviation 7.310	-9.96 Score on a scale Standard Deviation 7.888	-7.21 Score on a scale Standard Deviation 8.213	-7.86 Score on a scale Standard Deviation 8.572	-7.64 Score on a scale Standard Deviation 7.011	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 32, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.

POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 24	-11.75 Score on a scale Standard Deviation 7.086	-15.31 Score on a scale Standard Deviation 6.061	-11.97 Score on a scale Standard Deviation 6.410	-11.58 Score on a scale Standard Deviation 8.586	-9.25 Score on a scale Standard Deviation 8.347	-10.42 Score on a scale Standard Deviation 7.580	-14.00 Score on a scale Standard Deviation 6.205	-9.45 Score on a scale Standard Deviation 7.155	-8.75 Score on a scale Standard Deviation 7.197
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 32	-12.83 Score on a scale Standard Deviation 7.082	-14.69 Score on a scale Standard Deviation 8.499	-10.23 Score on a scale Standard Deviation 8.320	-11.91 Score on a scale Standard Deviation 8.240	-6.79 Score on a scale Standard Deviation 8.875	-11.32 Score on a scale Standard Deviation 8.113	-11.29 Score on a scale Standard Deviation 10.323	-9.42 Score on a scale Standard Deviation 7.784	-7.62 Score on a scale Standard Deviation 8.856
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 36	-13.00 Score on a scale Standard Deviation 7.019	-13.23 Score on a scale Standard Deviation 8.738	-9.91 Score on a scale Standard Deviation 8.129	-11.90 Score on a scale Standard Deviation 7.264	-7.00 Score on a scale Standard Deviation 8.932	-11.75 Score on a scale Standard Deviation 8.370	-12.57 Score on a scale Standard Deviation 9.502	-8.66 Score on a scale Standard Deviation 7.790	-7.93 Score on a scale Standard Deviation 7.966
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 40	-11.73 Score on a scale Standard Deviation 8.162	-13.92 Score on a scale Standard Deviation 8.411	-9.10 Score on a scale Standard Deviation 8.715	-11.00 Score on a scale Standard Deviation 6.633	-7.82 Score on a scale Standard Deviation 9.302	-11.88 Score on a scale Standard Deviation 8.698	-11.29 Score on a scale Standard Deviation 8.995	-8.81 Score on a scale Standard Deviation 8.300	-7.50 Score on a scale Standard Deviation 7.714
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 44	-11.92 Score on a scale Standard Deviation 8.262	-13.31 Score on a scale Standard Deviation 8.460	-9.81 Score on a scale Standard Deviation 8.920	-10.45 Score on a scale Standard Deviation 6.699	-6.50 Score on a scale Standard Deviation 8.804	-10.19 Score on a scale Standard Deviation 8.361	-7.86 Score on a scale Standard Deviation 7.515	-8.71 Score on a scale Standard Deviation 8.158	-7.93 Score on a scale Standard Deviation 7.908
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 48	-11.75 Score on a scale Standard Deviation 9.836	-11.69 Score on a scale Standard Deviation 9.861	-10.39 Score on a scale Standard Deviation 8.519	-11.50 Score on a scale Standard Deviation 6.916	-7.50 Score on a scale Standard Deviation 9.268	-10.33 Score on a scale Standard Deviation 8.125	-9.57 Score on a scale Standard Deviation 9.126	-9.90 Score on a scale Standard Deviation 8.660	-7.50 Score on a scale Standard Deviation 8.438
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 52	-10.64 Score on a scale Standard Deviation 10.053	-11.85 Score on a scale Standard Deviation 10.148	-9.13 Score on a scale Standard Deviation 8.320	-11.36 Score on a scale Standard Deviation 6.889	-6.82 Score on a scale Standard Deviation 9.318	-8.55 Score on a scale Standard Deviation 8.240	-10.00 Score on a scale Standard Deviation 9.452	-8.58 Score on a scale Standard Deviation 9.164	-8.50 Score on a scale Standard Deviation 9.146

SECONDARY outcome

Timeframe: Baseline to weeks 4, 8, 12, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.

POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 4	-8.99 Percentage of change Standard Deviation 39.554	-20.81 Percentage of change Standard Deviation 34.179	-21.02 Percentage of change Standard Deviation 31.360	-22.77 Percentage of change Standard Deviation 30.783	-17.94 Percentage of change Standard Deviation 30.152	—	—	—	—
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 8	-6.28 Percentage of change Standard Deviation 42.851	-33.06 Percentage of change Standard Deviation 41.272	-26.52 Percentage of change Standard Deviation 33.397	-26.62 Percentage of change Standard Deviation 34.946	-34.60 Percentage of change Standard Deviation 31.584	—	—	—	—
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 12	-8.04 Percentage of change Standard Deviation 41.445	-36.22 Percentage of change Standard Deviation 43.169	-32.42 Percentage of change Standard Deviation 32.145	-33.33 Percentage of change Standard Deviation 33.732	-34.61 Percentage of change Standard Deviation 34.275	—	—	—	—
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 16	-8.12 Percentage of change Standard Deviation 45.515	-37.08 Percentage of change Standard Deviation 52.391	-34.71 Percentage of change Standard Deviation 34.574	-32.78 Percentage of change Standard Deviation 36.449	-35.49 Percentage of change Standard Deviation 32.862	—	—	—	—
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 20	-8.32 Percentage of change Standard Deviation 44.942	-44.03 Percentage of change Standard Deviation 38.850	-34.23 Percentage of change Standard Deviation 38.938	-37.38 Percentage of change Standard Deviation 38.448	-35.37 Percentage of change Standard Deviation 36.589	—	—	—	—
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) Week 24	-6.98 Percentage of change Standard Deviation 49.837	-44.69 Percentage of change Standard Deviation 61.808	-33.91 Percentage of change Standard Deviation 48.273	-36.65 Percentage of change Standard Deviation 40.947	-36.81 Percentage of change Standard Deviation 34.444	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 32, 36, 40. 44, 48, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.

POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 24	-60.03 Percentage of change Standard Deviation 30.545	-72.61 Percentage of change Standard Deviation 19.898	-61.00 Percentage of change Standard Deviation 30.657	-54.05 Percentage of change Standard Deviation 38.147	-46.08 Percentage of change Standard Deviation 37.356	-51.61 Percentage of change Standard Deviation 35.438	-64.00 Percentage of change Standard Deviation 20.049	-45.63 Percentage of change Standard Deviation 34.579	-47.92 Percentage of change Standard Deviation 40.572
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 32	-64.21 Percentage of change Standard Deviation 28.981	-64.90 Percentage of change Standard Deviation 38.029	-50.03 Percentage of change Standard Deviation 44.543	-56.00 Percentage of change Standard Deviation 35.875	-30.61 Percentage of change Standard Deviation 39.689	-55.82 Percentage of change Standard Deviation 36.229	-47.30 Percentage of change Standard Deviation 57.463	-46.42 Percentage of change Standard Deviation 38.011	-43.95 Percentage of change Standard Deviation 50.962
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 36	-66.78 Percentage of change Standard Deviation 27.084	-60.09 Percentage of change Standard Deviation 40.508	-48.61 Percentage of change Standard Deviation 43.883	-57.09 Percentage of change Standard Deviation 34.068	-33.73 Percentage of change Standard Deviation 38.724	-57.38 Percentage of change Standard Deviation 37.436	-57.54 Percentage of change Standard Deviation 59.987	-43.35 Percentage of change Standard Deviation 40.000	-44.58 Percentage of change Standard Deviation 45.387
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 40	-58.98 Percentage of change Standard Deviation 33.289	-62.85 Percentage of change Standard Deviation 38.659	-44.35 Percentage of change Standard Deviation 45.524	-54.47 Percentage of change Standard Deviation 35.815	-37.89 Percentage of change Standard Deviation 40.032	-58.12 Percentage of change Standard Deviation 38.754	-49.79 Percentage of change Standard Deviation 55.862	-43.75 Percentage of change Standard Deviation 40.933	-42.88 Percentage of change Standard Deviation 45.567
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 44	-59.17 Percentage of change Standard Deviation 35.572	-60.83 Percentage of change Standard Deviation 40.648	-48.48 Percentage of change Standard Deviation 47.524	-52.24 Percentage of change Standard Deviation 36.218	-30.25 Percentage of change Standard Deviation 43.110	-50.10 Percentage of change Standard Deviation 37.814	-36.09 Percentage of change Standard Deviation 53.637	-43.16 Percentage of change Standard Deviation 39.688	-46.19 Percentage of change Standard Deviation 46.429
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 48	-58.18 Percentage of change Standard Deviation 46.077	-54.56 Percentage of change Standard Deviation 46.380	-51.53 Percentage of change Standard Deviation 44.857	-55.93 Percentage of change Standard Deviation 35.043	-35.37 Percentage of change Standard Deviation 42.309	-51.56 Percentage of change Standard Deviation 39.299	-44.04 Percentage of change Standard Deviation 58.904	-50.45 Percentage of change Standard Deviation 41.809	-43.48 Percentage of change Standard Deviation 48.292
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) Week 52	-52.64 Percentage of change Standard Deviation 47.556	-54.68 Percentage of change Standard Deviation 45.987	-44.51 Percentage of change Standard Deviation 43.725	-54.47 Percentage of change Standard Deviation 34.319	-29.38 Percentage of change Standard Deviation 46.373	-43.45 Percentage of change Standard Deviation 42.459	-48.82 Percentage of change Standard Deviation 63.478	-43.01 Percentage of change Standard Deviation 45.577	-47.62 Percentage of change Standard Deviation 50.785

SECONDARY outcome

Timeframe: Baseline to weeks 2, 8, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.

DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) Week 2	-2.09 Score on a scale Standard Deviation 4.710	-3.63 Score on a scale Standard Deviation 4.992	-2.82 Score on a scale Standard Deviation 4.850	-3.32 Score on a scale Standard Deviation 5.745	-3.40 Score on a scale Standard Deviation 5.131	—	—	—	—
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) Week 8	-2.43 Score on a scale Standard Deviation 5.466	-6.13 Score on a scale Standard Deviation 6.164	-5.59 Score on a scale Standard Deviation 5.553	-5.08 Score on a scale Standard Deviation 7.252	-7.13 Score on a scale Standard Deviation 5.954	—	—	—	—
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) Week 16	-2.35 Score on a scale Standard Deviation 6.069	-7.79 Score on a scale Standard Deviation 6.832	-6.25 Score on a scale Standard Deviation 6.246	-6.47 Score on a scale Standard Deviation 7.835	-7.76 Score on a scale Standard Deviation 6.265	—	—	—	—
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) Week 20	-2.39 Score on a scale Standard Deviation 6.391	-7.89 Score on a scale Standard Deviation 6.848	-6.42 Score on a scale Standard Deviation 6.833	-6.97 Score on a scale Standard Deviation 8.512	-7.31 Score on a scale Standard Deviation 7.132	—	—	—	—
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) Week 24	-2.30 Score on a scale Standard Deviation 6.406	-8.33 Score on a scale Standard Deviation 7.036	-6.54 Score on a scale Standard Deviation 6.384	-6.74 Score on a scale Standard Deviation 8.681	-7.69 Score on a scale Standard Deviation 7.230	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.

DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 24	-11.42 Score on a scale Standard Deviation 7.115	-12.54 Score on a scale Standard Deviation 6.703	-9.00 Score on a scale Standard Deviation 6.290	-9.08 Score on a scale Standard Deviation 6.487	-7.57 Score on a scale Standard Deviation 7.295	-8.26 Score on a scale Standard Deviation 9.338	-15.40 Score on a scale Standard Deviation 8.562	-9.67 Score on a scale Standard Deviation 7.712	-6.44 Score on a scale Standard Deviation 7.420
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 28	-11.33 Score on a scale Standard Deviation 7.832	-12.62 Score on a scale Standard Deviation 8.191	-9.52 Score on a scale Standard Deviation 6.929	-9.83 Score on a scale Standard Deviation 6.658	-7.21 Score on a scale Standard Deviation 6.488	-8.45 Score on a scale Standard Deviation 9.705	-12.29 Score on a scale Standard Deviation 9.232	-9.68 Score on a scale Standard Deviation 8.029	-5.77 Score on a scale Standard Deviation 8.633
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 32	-12.25 Score on a scale Standard Deviation 7.700	-12.38 Score on a scale Standard Deviation 8.272	-8.00 Score on a scale Standard Deviation 7.612	-8.55 Score on a scale Standard Deviation 8.238	-5.75 Score on a scale Standard Deviation 7.183	-8.50 Score on a scale Standard Deviation 9.629	-13.14 Score on a scale Standard Deviation 8.050	-9.13 Score on a scale Standard Deviation 7.906	-5.47 Score on a scale Standard Deviation 7.963
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 36	-12.58 Score on a scale Standard Deviation 7.716	-11.85 Score on a scale Standard Deviation 8.122	-7.72 Score on a scale Standard Deviation 7.985	-7.90 Score on a scale Standard Deviation 6.903	-6.18 Score on a scale Standard Deviation 7.222	-8.84 Score on a scale Standard Deviation 9.893	-14.00 Score on a scale Standard Deviation 8.446	-8.53 Score on a scale Standard Deviation 7.927	-5.93 Score on a scale Standard Deviation 7.839
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 40	-11.27 Score on a scale Standard Deviation 7.976	-12.23 Score on a scale Standard Deviation 7.715	-7.07 Score on a scale Standard Deviation 8.073	-7.18 Score on a scale Standard Deviation 5.456	-6.21 Score on a scale Standard Deviation 7.279	-8.06 Score on a scale Standard Deviation 9.844	-14.57 Score on a scale Standard Deviation 7.569	-8.23 Score on a scale Standard Deviation 8.281	-5.36 Score on a scale Standard Deviation 8.308
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 44	-12.08 Score on a scale Standard Deviation 8.426	-11.38 Score on a scale Standard Deviation 8.109	-7.19 Score on a scale Standard Deviation 7.943	-8.18 Score on a scale Standard Deviation 6.258	-5.68 Score on a scale Standard Deviation 7.029	-6.88 Score on a scale Standard Deviation 9.587	-10.29 Score on a scale Standard Deviation 7.889	-8.26 Score on a scale Standard Deviation 8.058	-5.93 Score on a scale Standard Deviation 6.889
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 48	-11.92 Score on a scale Standard Deviation 8.229	-9.92 Score on a scale Standard Deviation 6.800	-7.29 Score on a scale Standard Deviation 8.022	-8.40 Score on a scale Standard Deviation 7.516	-6.21 Score on a scale Standard Deviation 7.218	-6.83 Score on a scale Standard Deviation 9.322	-11.29 Score on a scale Standard Deviation 6.237	-7.93 Score on a scale Standard Deviation 7.891	-6.79 Score on a scale Standard Deviation 7.040
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 52	-12.55 Score on a scale Standard Deviation 9.136	-9.08 Score on a scale Standard Deviation 6.652	-6.83 Score on a scale Standard Deviation 7.852	-8.09 Score on a scale Standard Deviation 7.077	-5.93 Score on a scale Standard Deviation 7.383	-6.41 Score on a scale Standard Deviation 9.428	-11.57 Score on a scale Standard Deviation 6.705	-8.10 Score on a scale Standard Deviation 7.752	-6.64 Score on a scale Standard Deviation 6.902

SECONDARY outcome

Timeframe: Baseline to weeks 2, 8, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) Week 2	-10.30 Percentage of change Standard Deviation 37.999	-22.68 Percentage of change Standard Deviation 31.305	-11.95 Percentage of change Standard Deviation 47.921	-16.80 Percentage of change Standard Deviation 41.680	-22.73 Percentage of change Standard Deviation 32.711	—	—	—	—
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) Week 8	-13.12 Percentage of change Standard Deviation 42.775	-36.87 Percentage of change Standard Deviation 36.954	-36.14 Percentage of change Standard Deviation 41.176	-27.54 Percentage of change Standard Deviation 59.199	-45.85 Percentage of change Standard Deviation 32.198	—	—	—	—
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) Week 16	-11.35 Percentage of change Standard Deviation 51.739	-46.69 Percentage of change Standard Deviation 40.563	-41.27 Percentage of change Standard Deviation 43.616	-34.02 Percentage of change Standard Deviation 62.565	-48.96 Percentage of change Standard Deviation 29.801	—	—	—	—
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) Week 20	-12.08 Percentage of change Standard Deviation 49.973	-47.48 Percentage of change Standard Deviation 40.616	-42.90 Percentage of change Standard Deviation 46.336	-35.79 Percentage of change Standard Deviation 67.398	-44.33 Percentage of change Standard Deviation 36.816	—	—	—	—
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) Week 24	-11.91 Percentage of change Standard Deviation 55.694	-51.84 Percentage of change Standard Deviation 41.442	-42.36 Percentage of change Standard Deviation 45.550	-33.28 Percentage of change Standard Deviation 72.816	-45.63 Percentage of change Standard Deviation 33.860	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized Participants at week 24. Only those participants with data available at specified time points are reported.

DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 24	-72.47 Percentage of change Standard Deviation 27.818	-75.53 Percentage of change Standard Deviation 26.705	-61.64 Percentage of change Standard Deviation 35.809	-64.74 Percentage of change Standard Deviation 31.091	-44.26 Percentage of change Standard Deviation 57.217	-47.08 Percentage of change Standard Deviation 82.439	-70.77 Percentage of change Standard Deviation 27.653	-55.36 Percentage of change Standard Deviation 33.443	-48.30 Percentage of change Standard Deviation 57.726
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 28	-70.02 Percentage of change Standard Deviation 28.760	-72.50 Percentage of change Standard Deviation 37.184	-62.65 Percentage of change Standard Deviation 43.216	-71.77 Percentage of change Standard Deviation 29.970	-44.81 Percentage of change Standard Deviation 56.575	-48.86 Percentage of change Standard Deviation 83.936	-65.28 Percentage of change Standard Deviation 26.807	-55.62 Percentage of change Standard Deviation 34.382	-41.13 Percentage of change Standard Deviation 80.192
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 32	-77.14 Percentage of change Standard Deviation 26.277	-68.19 Percentage of change Standard Deviation 38.039	-48.69 Percentage of change Standard Deviation 56.833	-61.68 Percentage of change Standard Deviation 42.315	-31.65 Percentage of change Standard Deviation 55.087	-50.15 Percentage of change Standard Deviation 83.141	-72.98 Percentage of change Standard Deviation 17.074	-52.99 Percentage of change Standard Deviation 36.735	-41.18 Percentage of change Standard Deviation 68.097
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 36	-79.13 Percentage of change Standard Deviation 24.980	-65.76 Percentage of change Standard Deviation 35.792	-48.12 Percentage of change Standard Deviation 56.610	-60.50 Percentage of change Standard Deviation 41.018	-35.86 Percentage of change Standard Deviation 58.071	-52.16 Percentage of change Standard Deviation 84.141	-78.26 Percentage of change Standard Deviation 23.932	-49.48 Percentage of change Standard Deviation 43.137	-45.04 Percentage of change Standard Deviation 65.630
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 40	-72.31 Percentage of change Standard Deviation 27.268	-69.26 Percentage of change Standard Deviation 34.172	-44.78 Percentage of change Standard Deviation 59.798	-58.29 Percentage of change Standard Deviation 42.112	-36.52 Percentage of change Standard Deviation 58.909	-46.41 Percentage of change Standard Deviation 84.277	-83.18 Percentage of change Standard Deviation 16.284	-49.75 Percentage of change Standard Deviation 42.024	-38.69 Percentage of change Standard Deviation 80.196
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 44	-76.32 Percentage of change Standard Deviation 31.166	-63.03 Percentage of change Standard Deviation 41.237	-45.33 Percentage of change Standard Deviation 60.470	-63.04 Percentage of change Standard Deviation 42.005	-33.25 Percentage of change Standard Deviation 58.480	-39.27 Percentage of change Standard Deviation 83.804	-60.44 Percentage of change Standard Deviation 28.925	-49.15 Percentage of change Standard Deviation 43.228	-48.21 Percentage of change Standard Deviation 48.871
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 48	-73.10 Percentage of change Standard Deviation 28.704	-59.02 Percentage of change Standard Deviation 36.676	-45.68 Percentage of change Standard Deviation 59.933	-63.97 Percentage of change Standard Deviation 43.622	-35.98 Percentage of change Standard Deviation 57.915	-40.20 Percentage of change Standard Deviation 84.240	-70.04 Percentage of change Standard Deviation 26.437	-50.82 Percentage of change Standard Deviation 41.018	-57.92 Percentage of change Standard Deviation 45.339
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) Week 52	-72.35 Percentage of change Standard Deviation 33.768	-53.62 Percentage of change Standard Deviation 36.496	-43.64 Percentage of change Standard Deviation 56.804	-61.04 Percentage of change Standard Deviation 42.716	-33.21 Percentage of change Standard Deviation 59.514	-35.27 Percentage of change Standard Deviation 85.953	-71.56 Percentage of change Standard Deviation 28.287	-49.24 Percentage of change Standard Deviation 43.003	-57.12 Percentage of change Standard Deviation 44.899

SECONDARY outcome

Timeframe: Baseline to weeks 16, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) Week 16	-2.50 Score on a scale Standard Deviation 4.589	-6.70 Score on a scale Standard Deviation 5.813	-5.41 Score on a scale Standard Deviation 6.054	-6.22 Score on a scale Standard Deviation 6.272	-6.61 Score on a scale Standard Deviation 5.804	—	—	—	—
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) Week 24	-1.90 Score on a scale Standard Deviation 5.046	-7.35 Score on a scale Standard Deviation 6.695	-5.80 Score on a scale Standard Deviation 6.187	-6.70 Score on a scale Standard Deviation 6.566	-6.66 Score on a scale Standard Deviation 5.868	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 36 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.

ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) Week 24	-9.83 Score on a scale Standard Deviation 5.132	-11.23 Score on a scale Standard Deviation 6.071	-8.64 Score on a scale Standard Deviation 5.927	-9.83 Score on a scale Standard Deviation 6.506	-7.44 Score on a scale Standard Deviation 5.673	-8.42 Score on a scale Standard Deviation 6.386	-12.60 Score on a scale Standard Deviation 6.986	-8.29 Score on a scale Standard Deviation 5.996	-6.25 Score on a scale Standard Deviation 6.083
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) Week 36	-10.33 Score on a scale Standard Deviation 5.483	-11.46 Score on a scale Standard Deviation 5.681	-8.13 Score on a scale Standard Deviation 6.463	-8.20 Score on a scale Standard Deviation 6.143	-7.78 Score on a scale Standard Deviation 6.123	-9.26 Score on a scale Standard Deviation 6.875	-10.71 Score on a scale Standard Deviation 6.550	-8.03 Score on a scale Standard Deviation 6.385	-6.38 Score on a scale Standard Deviation 6.063
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) Week 52	-10.45 Score on a scale Standard Deviation 5.989	-11.31 Score on a scale Standard Deviation 4.768	-8.30 Score on a scale Standard Deviation 5.706	-8.82 Score on a scale Standard Deviation 6.809	-7.44 Score on a scale Standard Deviation 6.594	-6.48 Score on a scale Standard Deviation 6.539	-9.71 Score on a scale Standard Deviation 4.751	-8.34 Score on a scale Standard Deviation 6.893	-7.14 Score on a scale Standard Deviation 6.125

SECONDARY outcome

Timeframe: Baseline to weeks 16, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) Week 16	-17.04 Percentage of change Standard Deviation 32.553	-40.56 Percentage of change Standard Deviation 37.340	-33.42 Percentage of change Standard Deviation 34.745	-36.42 Percentage of change Standard Deviation 37.103	-38.72 Percentage of change Standard Deviation 30.762	—	—	—	—
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) Week 24	-12.31 Percentage of change Standard Deviation 37.504	-45.18 Percentage of change Standard Deviation 42.438	-36.20 Percentage of change Standard Deviation 41.363	-40.45 Percentage of change Standard Deviation 40.708	-39.35 Percentage of change Standard Deviation 31.799	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 36 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.

ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) Week 24	-65.46 Percentage of change Standard Deviation 26.823	-66.75 Percentage of change Standard Deviation 32.632	-57.08 Percentage of change Standard Deviation 37.656	-56.01 Percentage of change Standard Deviation 36.112	-49.97 Percentage of change Standard Deviation 34.078	-53.10 Percentage of change Standard Deviation 40.207	-63.92 Percentage of change Standard Deviation 29.784	-50.66 Percentage of change Standard Deviation 33.458	-44.95 Percentage of change Standard Deviation 45.331
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) Week 36	-69.73 Percentage of change Standard Deviation 28.925	-69.01 Percentage of change Standard Deviation 29.493	-50.38 Percentage of change Standard Deviation 42.649	-50.01 Percentage of change Standard Deviation 37.199	-50.87 Percentage of change Standard Deviation 33.197	-58.44 Percentage of change Standard Deviation 43.340	-62.63 Percentage of change Standard Deviation 23.130	-48.59 Percentage of change Standard Deviation 38.274	-49.42 Percentage of change Standard Deviation 45.902
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) Week 52	-67.84 Percentage of change Standard Deviation 32.469	-69.93 Percentage of change Standard Deviation 26.250	-54.77 Percentage of change Standard Deviation 34.128	-52.75 Percentage of change Standard Deviation 41.167	-47.15 Percentage of change Standard Deviation 39.681	-41.39 Percentage of change Standard Deviation 43.875	-64.19 Percentage of change Standard Deviation 28.274	-50.29 Percentage of change Standard Deviation 41.341	-53.35 Percentage of change Standard Deviation 47.196

SECONDARY outcome

Timeframe: Baseline to weeks 8 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 8	-0.97 Score on a scale Standard Deviation 3.940	-2.20 Score on a scale Standard Deviation 4.639	-2.07 Score on a scale Standard Deviation 6.194	-2.35 Score on a scale Standard Deviation 5.641	-3.29 Score on a scale Standard Deviation 5.132	—	—	—	—
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 16	-0.57 Score on a scale Standard Deviation 5.088	-2.67 Score on a scale Standard Deviation 5.761	-2.53 Score on a scale Standard Deviation 6.510	-3.04 Score on a scale Standard Deviation 6.292	-3.74 Score on a scale Standard Deviation 6.401	—	—	—	—
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 20	-0.66 Score on a scale Standard Deviation 4.176	-2.52 Score on a scale Standard Deviation 7.254	-2.35 Score on a scale Standard Deviation 7.326	-3.38 Score on a scale Standard Deviation 6.787	-4.24 Score on a scale Standard Deviation 5.873	—	—	—	—
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 24	-0.97 Score on a scale Standard Deviation 4.196	-2.96 Score on a scale Standard Deviation 7.550	-2.30 Score on a scale Standard Deviation 6.880	-2.83 Score on a scale Standard Deviation 6.818	-4.00 Score on a scale Standard Deviation 6.802	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.

The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 24	-3.67 score on a scale Standard Deviation 6.998	-4.54 score on a scale Standard Deviation 8.482	-1.73 score on a scale Standard Deviation 7.434	-5.58 score on a scale Standard Deviation 10.184	-2.81 score on a scale Standard Deviation 6.822	-4.42 score on a scale Standard Deviation 7.890	-8.20 score on a scale Standard Deviation 6.340	-4.03 score on a scale Standard Deviation 6.710	-0.38 score on a scale Standard Deviation 4.660
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 28	-4.33 score on a scale Standard Deviation 7.679	-3.54 score on a scale Standard Deviation 7.965	-2.52 score on a scale Standard Deviation 6.205	-6.50 score on a scale Standard Deviation 11.430	-2.70 score on a scale Standard Deviation 6.916	-4.97 score on a scale Standard Deviation 8.428	-7.29 score on a scale Standard Deviation 5.251	-5.26 score on a scale Standard Deviation 7.034	0.38 score on a scale Standard Deviation 4.753
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 32	-4.42 score on a scale Standard Deviation 7.242	-3.38 score on a scale Standard Deviation 8.893	-1.24 score on a scale Standard Deviation 6.996	-4.09 score on a scale Standard Deviation 9.027	-2.74 score on a scale Standard Deviation 7.593	-5.66 score on a scale Standard Deviation 8.280	-6.86 score on a scale Standard Deviation 5.460	-3.97 score on a scale Standard Deviation 6.483	-0.20 score on a scale Standard Deviation 4.491
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 36	-4.42 score on a scale Standard Deviation 6.999	-1.85 score on a scale Standard Deviation 9.754	-1.22 score on a scale Standard Deviation 8.015	-3.80 score on a scale Standard Deviation 10.497	-2.52 score on a scale Standard Deviation 5.833	-5.50 score on a scale Standard Deviation 8.828	-7.14 score on a scale Standard Deviation 4.880	-3.75 score on a scale Standard Deviation 7.878	0.29 score on a scale Standard Deviation 4.250
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 40	-3.55 score on a scale Standard Deviation 7.594	-2.92 score on a scale Standard Deviation 8.864	-1.40 score on a scale Standard Deviation 6.966	-3.09 score on a scale Standard Deviation 10.222	-2.70 score on a scale Standard Deviation 6.151	-5.16 score on a scale Standard Deviation 8.674	-7.43 score on a scale Standard Deviation 5.563	-3.29 score on a scale Standard Deviation 5.593	0.50 score on a scale Standard Deviation 5.125
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 44	-4.25 score on a scale Standard Deviation 7.225	-2.69 score on a scale Standard Deviation 8.873	-0.29 score on a scale Standard Deviation 6.963	-3.45 score on a scale Standard Deviation 10.511	-3.07 score on a scale Standard Deviation 5.313	-4.56 score on a scale Standard Deviation 8.879	-5.43 score on a scale Standard Deviation 5.192	-3.71 score on a scale Standard Deviation 7.408	-0.21 score on a scale Standard Deviation 4.318
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 48	-3.33 score on a scale Standard Deviation 7.797	-3.08 score on a scale Standard Deviation 8.883	-0.68 score on a scale Standard Deviation 7.078	-4.40 score on a scale Standard Deviation 10.024	-2.85 score on a scale Standard Deviation 5.559	-5.23 score on a scale Standard Deviation 8.724	-7.43 score on a scale Standard Deviation 5.412	-4.17 score on a scale Standard Deviation 7.269	-1.00 score on a scale Standard Deviation 4.852
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 52	-4.18 score on a scale Standard Deviation 7.167	-2.46 score on a scale Standard Deviation 9.162	-0.80 score on a scale Standard Deviation 7.092	-2.55 score on a scale Standard Deviation 8.359	-3.00 score on a scale Standard Deviation 5.877	-4.59 score on a scale Standard Deviation 8.454	-7.29 score on a scale Standard Deviation 5.794	-3.13 score on a scale Standard Deviation 8.082	-0.64 score on a scale Standard Deviation 5.719

SECONDARY outcome

Timeframe: Baseline to weeks 8, 16, 20, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 8	-0.66 Percentage of change Standard Deviation 77.969	-18.40 Percentage of change Standard Deviation 46.151	-11.76 Percentage of change Standard Deviation 48.829	-10.22 Percentage of change Standard Deviation 56.395	-13.15 Percentage of change Standard Deviation 69.427	—	—	—	—
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 16	2.82 Percentage of change Standard Deviation 101.930	-18.12 Percentage of change Standard Deviation 56.175	-11.72 Percentage of change Standard Deviation 54.678	-15.84 Percentage of change Standard Deviation 54.001	-17.47 Percentage of change Standard Deviation 94.346	—	—	—	—
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 20	-5.02 Percentage of change Standard Deviation 78.180	-20.15 Percentage of change Standard Deviation 65.506	-7.39 Percentage of change Standard Deviation 62.693	-17.62 Percentage of change Standard Deviation 59.518	-25.97 Percentage of change Standard Deviation 83.249	—	—	—	—
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) Week 24	-8.17 Percentage of change Standard Deviation 77.872	-13.22 Percentage of change Standard Deviation 97.953	-8.67 Percentage of change Standard Deviation 60.563	-17.75 Percentage of change Standard Deviation 52.049	-12.07 Percentage of change Standard Deviation 120.061	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.

The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 24	-20.28 Percentage of change Standard Deviation 49.825	-28.01 Percentage of change Standard Deviation 54.369	-17.89 Percentage of change Standard Deviation 76.693	-34.27 Percentage of change Standard Deviation 48.841	-13.63 Percentage of change Standard Deviation 65.697	-32.24 Percentage of change Standard Deviation 65.070	-46.94 Percentage of change Standard Deviation 22.063	-22.38 Percentage of change Standard Deviation 58.898	-32.55 Percentage of change Standard Deviation 66.184
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 28	4.22 Percentage of change Standard Deviation 96.782	-18.57 Percentage of change Standard Deviation 53.870	-22.56 Percentage of change Standard Deviation 67.645	-30.97 Percentage of change Standard Deviation 51.945	-17.92 Percentage of change Standard Deviation 53.098	-30.52 Percentage of change Standard Deviation 66.305	-49.58 Percentage of change Standard Deviation 31.509	-33.17 Percentage of change Standard Deviation 41.412	-38.39 Percentage of change Standard Deviation 77.030
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 32	-11.36 Percentage of change Standard Deviation 87.084	-19.06 Percentage of change Standard Deviation 60.844	-14.02 Percentage of change Standard Deviation 82.893	-29.10 Percentage of change Standard Deviation 52.035	-20.31 Percentage of change Standard Deviation 63.189	-43.96 Percentage of change Standard Deviation 68.306	-42.56 Percentage of change Standard Deviation 27.759	-32.62 Percentage of change Standard Deviation 49.764	-38.06 Percentage of change Standard Deviation 69.176
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 36	-8.75 Percentage of change Standard Deviation 85.214	11.76 Percentage of change Standard Deviation 84.979	-9.44 Percentage of change Standard Deviation 81.662	-6.28 Percentage of change Standard Deviation 62.772	-22.30 Percentage of change Standard Deviation 51.020	-37.19 Percentage of change Standard Deviation 71.372	-51.27 Percentage of change Standard Deviation 29.960	-32.59 Percentage of change Standard Deviation 49.531	-9.11 Percentage of change Standard Deviation 110.289
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 40	4.24 Percentage of change Standard Deviation 91.941	-13.29 Percentage of change Standard Deviation 60.249	-18.23 Percentage of change Standard Deviation 79.025	7.25 Percentage of change Standard Deviation 82.513	-21.32 Percentage of change Standard Deviation 50.659	-40.11 Percentage of change Standard Deviation 67.991	-56.66 Percentage of change Standard Deviation 33.879	-35.92 Percentage of change Standard Deviation 46.888	-1.02 Percentage of change Standard Deviation 98.096
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 44	-15.90 Percentage of change Standard Deviation 85.382	-2.42 Percentage of change Standard Deviation 54.527	-5.30 Percentage of change Standard Deviation 88.418	-23.23 Percentage of change Standard Deviation 56.824	-31.88 Percentage of change Standard Deviation 49.100	-30.93 Percentage of change Standard Deviation 71.891	-41.44 Percentage of change Standard Deviation 37.143	-32.73 Percentage of change Standard Deviation 57.357	-22.21 Percentage of change Standard Deviation 80.062
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 48	4.97 Percentage of change Standard Deviation 88.017	-14.15 Percentage of change Standard Deviation 60.660	-4.47 Percentage of change Standard Deviation 95.509	-28.27 Percentage of change Standard Deviation 51.499	-21.89 Percentage of change Standard Deviation 53.010	-39.36 Percentage of change Standard Deviation 69.672	-60.77 Percentage of change Standard Deviation 35.190	-36.32 Percentage of change Standard Deviation 47.746	-34.95 Percentage of change Standard Deviation 67.833
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) Week 52	0.43 Percentage of change Standard Deviation 85.522	-8.10 Percentage of change Standard Deviation 67.182	-7.59 Percentage of change Standard Deviation 92.868	-13.70 Percentage of change Standard Deviation 44.085	-19.98 Percentage of change Standard Deviation 56.405	-14.22 Percentage of change Standard Deviation 78.739	-59.23 Percentage of change Standard Deviation 37.434	-23.84 Percentage of change Standard Deviation 50.933	-18.16 Percentage of change Standard Deviation 69.310

SECONDARY outcome

Timeframe: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 1	-0.28 score on a scale Standard Deviation 1.071	-0.54 score on a scale Standard Deviation 1.096	-0.56 score on a scale Standard Deviation 0.978	-0.49 score on a scale Standard Deviation 0.965	-0.45 score on a scale Standard Deviation 0.908	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 2	-0.42 score on a scale Standard Deviation 1.046	-0.65 score on a scale Standard Deviation 1.316	-0.79 score on a scale Standard Deviation 1.367	-0.73 score on a scale Standard Deviation 1.075	-0.81 score on a scale Standard Deviation 1.224	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 3	-0.65 score on a scale Standard Deviation 1.567	-0.90 score on a scale Standard Deviation 1.619	-0.92 score on a scale Standard Deviation 1.392	-1.05 score on a scale Standard Deviation 1.302	-0.88 score on a scale Standard Deviation 1.478	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 4	-0.77 score on a scale Standard Deviation 1.744	-.096 score on a scale Standard Deviation 1.672	-1.25 score on a scale Standard Deviation 1.657	-1.36 score on a scale Standard Deviation 1.443	-1.09 score on a scale Standard Deviation 1.668	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 5	-0.83 score on a scale Standard Deviation 2.030	-0.99 score on a scale Standard Deviation 1.811	-1.38 score on a scale Standard Deviation 1.653	-1.42 score on a scale Standard Deviation 1.591	-1.49 score on a scale Standard Deviation 1.799	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 6	-0.94 score on a scale Standard Deviation 1.899	-1.09 score on a scale Standard Deviation 1.679	-1.35 score on a scale Standard Deviation 1.818	-1.38 score on a scale Standard Deviation 1.666	-1.58 score on a scale Standard Deviation 2.057	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 7	-0.78 score on a scale Standard Deviation 1.922	-1.25 score on a scale Standard Deviation 1.966	-1.54 score on a scale Standard Deviation 1.850	-1.57 score on a scale Standard Deviation 1.710	-1.78 score on a scale Standard Deviation 2.002	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 8	-0.80 score on a scale Standard Deviation 1.979	-1.42 score on a scale Standard Deviation 2.062	-1.50 score on a scale Standard Deviation 1.786	-1.60 score on a scale Standard Deviation 1.816	-1.93 score on a scale Standard Deviation 2.053	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 9	-1.00 score on a scale Standard Deviation 2.142	-1.44 score on a scale Standard Deviation 2.104	-1.52 score on a scale Standard Deviation 1.805	-1.89 score on a scale Standard Deviation 1.885	-2.13 score on a scale Standard Deviation 2.031	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 10	-0.97 score on a scale Standard Deviation 2.244	-1.62 score on a scale Standard Deviation 2.162	-1.67 score on a scale Standard Deviation 1.852	-1.82 score on a scale Standard Deviation 2.082	-2.17 score on a scale Standard Deviation 2.137	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 11	-0.93 score on a scale Standard Deviation 2.111	-1.68 score on a scale Standard Deviation 2.176	-1.67 score on a scale Standard Deviation 1.936	-2.06 score on a scale Standard Deviation 2.091	-2.31 score on a scale Standard Deviation 2.248	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 12	-0.79 score on a scale Standard Deviation 2.162	-1.70 score on a scale Standard Deviation 2.204	-1.65 score on a scale Standard Deviation 2.074	-1.96 score on a scale Standard Deviation 2.107	-2.28 score on a scale Standard Deviation 2.262	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 13	-0.72 score on a scale Standard Deviation 2.087	-1.83 score on a scale Standard Deviation 2.295	-1.87 score on a scale Standard Deviation 2.247	-2.05 score on a scale Standard Deviation 2.164	-2.28 score on a scale Standard Deviation 2.291	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 14	-0.58 score on a scale Standard Deviation 2.055	-1.82 score on a scale Standard Deviation 2.355	-2.02 score on a scale Standard Deviation 2.468	-2.13 score on a scale Standard Deviation 2.308	-2.35 score on a scale Standard Deviation 2.316	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 15	-0.57 score on a scale Standard Deviation 2.018	-1.87 score on a scale Standard Deviation 2.386	-2.08 score on a scale Standard Deviation 2.511	-2.10 score on a scale Standard Deviation 2.290	-2.32 score on a scale Standard Deviation 2.288	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 16	-0.54 score on a scale Standard Deviation 2.077	-2.06 score on a scale Standard Deviation 2.539	-2.09 score on a scale Standard Deviation 2.497	-2.22 score on a scale Standard Deviation 2.275	-2.31 score on a scale Standard Deviation 2.301	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 17	-0.61 score on a scale Standard Deviation 2.143	-2.13 score on a scale Standard Deviation 2.465	-2.18 score on a scale Standard Deviation 2.457	-2.14 score on a scale Standard Deviation 2.368	-2.35 score on a scale Standard Deviation 2.346	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 18	-0.55 score on a scale Standard Deviation 2.168	-2.18 score on a scale Standard Deviation 2.534	-2.21 score on a scale Standard Deviation 2.543	-2.16 score on a scale Standard Deviation 2.307	-2.37 score on a scale Standard Deviation 2.383	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 19	-0.75 score on a scale Standard Deviation 2.278	-2.19 score on a scale Standard Deviation 2.484	-2.22 score on a scale Standard Deviation 2.563	-2.14 score on a scale Standard Deviation 2.291	-2.38 score on a scale Standard Deviation 2.463	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 20	-0.67 score on a scale Standard Deviation 2.201	-2.28 score on a scale Standard Deviation 2.522	-2.19 score on a scale Standard Deviation 2.530	-2.13 score on a scale Standard Deviation 2.360	-2.31 score on a scale Standard Deviation 2.401	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 21	-0.76 score on a scale Standard Deviation 2.332	-2.28 score on a scale Standard Deviation 2.516	-2.23 score on a scale Standard Deviation 2.576	-2.27 score on a scale Standard Deviation 2.352	-2.43 score on a scale Standard Deviation 2.404	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 22	-0.73 score on a scale Standard Deviation 2.314	-2.38 score on a scale Standard Deviation 2.622	-2.29 score on a scale Standard Deviation 2.699	-2.25 score on a scale Standard Deviation 2.438	-2.44 score on a scale Standard Deviation 2.383	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 23	-0.61 score on a scale Standard Deviation 2.215	-2.56 score on a scale Standard Deviation 2.671	-2.27 score on a scale Standard Deviation 2.538	-2.20 score on a scale Standard Deviation 2.529	-2.59 score on a scale Standard Deviation 2.453	—	—	—	—
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 24	-0.55 score on a scale Standard Deviation 2.224	-2.58 score on a scale Standard Deviation 2.662	-2.30 score on a scale Standard Deviation 2.672	-2.21 score on a scale Standard Deviation 2.616	-2.46 score on a scale Standard Deviation 2.427	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 33	-4.32 Score on a scale Standard Deviation 2.316	-3.60 Score on a scale Standard Deviation 2.722	-2.49 Score on a scale Standard Deviation 3.220	-3.06 Score on a scale Standard Deviation 2.755	-1.85 Score on a scale Standard Deviation 2.867	-2.83 Score on a scale Standard Deviation 2.579	-4.14 Score on a scale Standard Deviation 1.843	-2.66 Score on a scale Standard Deviation 2.705	-1.45 Score on a scale Standard Deviation 3.332
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 24	-4.34 Score on a scale Standard Deviation 2.169	-3.63 Score on a scale Standard Deviation 2.380	-2.83 Score on a scale Standard Deviation 2.909	-4.00 Score on a scale Standard Deviation 2.711	-2.25 Score on a scale Standard Deviation 2.861	-2.92 Score on a scale Standard Deviation 2.539	-4.63 Score on a scale Standard Deviation 1.822	-2.82 Score on a scale Standard Deviation 2.571	-1.95 Score on a scale Standard Deviation 3.083
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 25	-4.12 Score on a scale Standard Deviation 2.413	-3.83 Score on a scale Standard Deviation 2.353	-2.73 Score on a scale Standard Deviation 2.973	-4.08 Score on a scale Standard Deviation 2.726	-2.42 Score on a scale Standard Deviation 2.895	-2.81 Score on a scale Standard Deviation 2.405	-4.92 Score on a scale Standard Deviation 1.863	-2.64 Score on a scale Standard Deviation 2.577	-2.08 Score on a scale Standard Deviation 3.177
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 26	-3.83 Score on a scale Standard Deviation 2.428	-3.82 Score on a scale Standard Deviation 2.442	-2.71 Score on a scale Standard Deviation 2.891	-3.75 Score on a scale Standard Deviation 2.654	-2.33 Score on a scale Standard Deviation 3.096	-2.56 Score on a scale Standard Deviation 2.400	-4.56 Score on a scale Standard Deviation 1.903	-2.70 Score on a scale Standard Deviation 2.634	-1.93 Score on a scale Standard Deviation 3.202
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 27	-4.09 Score on a scale Standard Deviation 2.567	-3.84 Score on a scale Standard Deviation 2.444	-2.58 Score on a scale Standard Deviation 2.819	-3.65 Score on a scale Standard Deviation 2.619	-2.28 Score on a scale Standard Deviation 2.994	-2.84 Score on a scale Standard Deviation 2.467	-4.51 Score on a scale Standard Deviation 1.790	-2.57 Score on a scale Standard Deviation 2.748	-2.04 Score on a scale Standard Deviation 3.351
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 28	-4.02 Score on a scale Standard Deviation 2.525	-3.86 Score on a scale Standard Deviation 2.432	-2.56 Score on a scale Standard Deviation 2.892	-3.59 Score on a scale Standard Deviation 2.575	-2.29 Score on a scale Standard Deviation 2.782	-3.01 Score on a scale Standard Deviation 2.504	-4.38 Score on a scale Standard Deviation 1.827	-2.75 Score on a scale Standard Deviation 2.753	-1.89 Score on a scale Standard Deviation 3.459
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 29	-4.16 Score on a scale Standard Deviation 2.387	-3.73 Score on a scale Standard Deviation 2.612	-2.51 Score on a scale Standard Deviation 2.874	-3.81 Score on a scale Standard Deviation 2.425	-1.85 Score on a scale Standard Deviation 2.733	-2.99 Score on a scale Standard Deviation 2.591	-4.50 Score on a scale Standard Deviation 2.035	-2.64 Score on a scale Standard Deviation 2.695	-1.81 Score on a scale Standard Deviation 3.386
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 30	-4.44 Score on a scale Standard Deviation 2.526	-3.32 Score on a scale Standard Deviation 2.564	-2.78 Score on a scale Standard Deviation 3.030	-3.76 Score on a scale Standard Deviation 2.394	-2.07 Score on a scale Standard Deviation 2.564	-2.68 Score on a scale Standard Deviation 2.490	-3.73 Score on a scale Standard Deviation 2.125	-2.59 Score on a scale Standard Deviation 2.653	-1.80 Score on a scale Standard Deviation 3.445
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 31	-4.18 Score on a scale Standard Deviation 2.428	-3.41 Score on a scale Standard Deviation 2.580	-2.74 Score on a scale Standard Deviation 3.213	-3.73 Score on a scale Standard Deviation 2.431	-1.71 Score on a scale Standard Deviation 2.980	-2.81 Score on a scale Standard Deviation 2.662	-4.02 Score on a scale Standard Deviation 2.280	-2.78 Score on a scale Standard Deviation 2.691	-1.46 Score on a scale Standard Deviation 3.132
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 32	-4.27 Score on a scale Standard Deviation 2.261	-3.43 Score on a scale Standard Deviation 2.607	-2.56 Score on a scale Standard Deviation 3.098	-3.13 Score on a scale Standard Deviation 2.818	-1.51 Score on a scale Standard Deviation 2.736	-2.86 Score on a scale Standard Deviation 2.617	-4.40 Score on a scale Standard Deviation 2.170	-2.68 Score on a scale Standard Deviation 2.674	-1.54 Score on a scale Standard Deviation 3.221
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 34	-4.43 Score on a scale Standard Deviation 2.297	-3.49 Score on a scale Standard Deviation 2.644	-2.26 Score on a scale Standard Deviation 3.114	-3.32 Score on a scale Standard Deviation 2.732	-1.30 Score on a scale Standard Deviation 2.792	-2.84 Score on a scale Standard Deviation 2.508	-3.97 Score on a scale Standard Deviation 1.948	-2.58 Score on a scale Standard Deviation 2.665	-1.86 Score on a scale Standard Deviation 3.578
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 35	-4.60 Score on a scale Standard Deviation 2.497	-3.47 Score on a scale Standard Deviation 2.712	-2.51 Score on a scale Standard Deviation 3.219	-3.09 Score on a scale Standard Deviation 2.600	-1.42 Score on a scale Standard Deviation 2.685	-3.01 Score on a scale Standard Deviation 2.529	-4.55 Score on a scale Standard Deviation 2.055	-2.65 Score on a scale Standard Deviation 2.674	-1.86 Score on a scale Standard Deviation 3.390
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 36	-4.67 Score on a scale Standard Deviation 2.468	-3.48 Score on a scale Standard Deviation 2.752	-2.47 Score on a scale Standard Deviation 3.262	-2.81 Score on a scale Standard Deviation 2.693	-1.64 Score on a scale Standard Deviation 2.670	-2.90 Score on a scale Standard Deviation 2.527	-4.14 Score on a scale Standard Deviation 1.845	-2.39 Score on a scale Standard Deviation 2.626	-1.56 Score on a scale Standard Deviation 3.318
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 37	-4.51 Score on a scale Standard Deviation 2.429	-3.44 Score on a scale Standard Deviation 2.726	-2.53 Score on a scale Standard Deviation 3.244	-2.50 Score on a scale Standard Deviation 2.523	-1.85 Score on a scale Standard Deviation 2.758	-3.11 Score on a scale Standard Deviation 2.508	-4.49 Score on a scale Standard Deviation 1.992	-2.33 Score on a scale Standard Deviation 2.564	-1.58 Score on a scale Standard Deviation 3.328
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 38	-4.57 Score on a scale Standard Deviation 2.505	-3.31 Score on a scale Standard Deviation 3.182	-2.33 Score on a scale Standard Deviation 3.159	-2.06 Score on a scale Standard Deviation 2.464	-1.74 Score on a scale Standard Deviation 2.803	-3.16 Score on a scale Standard Deviation 2.672	-4.52 Score on a scale Standard Deviation 2.046	-2.37 Score on a scale Standard Deviation 2.548	-1.64 Score on a scale Standard Deviation 3.449
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 39	-4.24 Score on a scale Standard Deviation 2.451	-3.34 Score on a scale Standard Deviation 3.206	-2.35 Score on a scale Standard Deviation 3.212	-2.52 Score on a scale Standard Deviation 2.462	-1.81 Score on a scale Standard Deviation 2.792	-3.07 Score on a scale Standard Deviation 2.548	-4.66 Score on a scale Standard Deviation 2.070	-2.27 Score on a scale Standard Deviation 2.605	-1.78 Score on a scale Standard Deviation 3.350
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 40	-4.24 Score on a scale Standard Deviation 2.419	-3.29 Score on a scale Standard Deviation 3.245	-2.26 Score on a scale Standard Deviation 3.208	-2.11 Score on a scale Standard Deviation 2.064	-1.74 Score on a scale Standard Deviation 2.697	-2.92 Score on a scale Standard Deviation 2.574	-2.98 Score on a scale Standard Deviation 1.946	-2.38 Score on a scale Standard Deviation 2.659	-1.67 Score on a scale Standard Deviation 3.413
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 41	-4.56 Score on a scale Standard Deviation 2.344	-3.25 Score on a scale Standard Deviation 3.188	-2.26 Score on a scale Standard Deviation 3.213	-1.82 Score on a scale Standard Deviation 1.991	-1.97 Score on a scale Standard Deviation 2.774	-2.67 Score on a scale Standard Deviation 2.798	-3.73 Score on a scale Standard Deviation 2.142	-2.41 Score on a scale Standard Deviation 2.697	-1.64 Score on a scale Standard Deviation 3.856
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 42	-4.67 Score on a scale Standard Deviation 2.494	-3.21 Score on a scale Standard Deviation 3.218	-2.28 Score on a scale Standard Deviation 3.307	-2.53 Score on a scale Standard Deviation 2.603	-1.91 Score on a scale Standard Deviation 2.835	-2.92 Score on a scale Standard Deviation 2.876	-3.78 Score on a scale Standard Deviation 2.183	-2.24 Score on a scale Standard Deviation 2.655	-2.01 Score on a scale Standard Deviation 3.719
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 43	-4.64 Score on a scale Standard Deviation 2.864	-3.30 Score on a scale Standard Deviation 3.246	-2.27 Score on a scale Standard Deviation 3.158	-2.53 Score on a scale Standard Deviation 2.523	-1.74 Score on a scale Standard Deviation 2.821	-2.82 Score on a scale Standard Deviation 2.612	-3.70 Score on a scale Standard Deviation 2.063	-2.22 Score on a scale Standard Deviation 2.736	-2.31 Score on a scale Standard Deviation 3.823
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 44	-4.83 Score on a scale Standard Deviation 2.484	-3.34 Score on a scale Standard Deviation 3.276	-2.31 Score on a scale Standard Deviation 3.196	-2.37 Score on a scale Standard Deviation 2.349	-1.79 Score on a scale Standard Deviation 2.690	-2.81 Score on a scale Standard Deviation 2.693	-3.51 Score on a scale Standard Deviation 2.084	-2.21 Score on a scale Standard Deviation 2.656	-2.01 Score on a scale Standard Deviation 3.730
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 45	-4.68 Score on a scale Standard Deviation 2.637	-3.63 Score on a scale Standard Deviation 3.034	-2.41 Score on a scale Standard Deviation 3.267	-1.97 Score on a scale Standard Deviation 2.110	-1.87 Score on a scale Standard Deviation 2.745	-2.62 Score on a scale Standard Deviation 2.636	-3.58 Score on a scale Standard Deviation 1.992	-2.23 Score on a scale Standard Deviation 2.678	-1.87 Score on a scale Standard Deviation 3.752
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 46	-4.41 Score on a scale Standard Deviation 2.864	-3.29 Score on a scale Standard Deviation 3.359	-2.46 Score on a scale Standard Deviation 3.219	-2.61 Score on a scale Standard Deviation 2.550	-1.84 Score on a scale Standard Deviation 2.679	-2.33 Score on a scale Standard Deviation 2.614	-3.78 Score on a scale Standard Deviation 2.146	-2.28 Score on a scale Standard Deviation 2.713	-1.99 Score on a scale Standard Deviation 4.071
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 47	-4.46 Score on a scale Standard Deviation 2.830	-3.17 Score on a scale Standard Deviation 3.283	-2.31 Score on a scale Standard Deviation 3.183	-1.95 Score on a scale Standard Deviation 2.320	-1.84 Score on a scale Standard Deviation 2.796	-2.30 Score on a scale Standard Deviation 2.731	-3.66 Score on a scale Standard Deviation 2.139	-2.38 Score on a scale Standard Deviation 2.645	-1.78 Score on a scale Standard Deviation 3.762
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 48	-4.64 Score on a scale Standard Deviation 2.892	-2.82 Score on a scale Standard Deviation 3.247	-2.43 Score on a scale Standard Deviation 3.202	-2.36 Score on a scale Standard Deviation 2.366	-1.84 Score on a scale Standard Deviation 2.761	-2.04 Score on a scale Standard Deviation 2.636	-3.96 Score on a scale Standard Deviation 2.251	-2.31 Score on a scale Standard Deviation 2.731	-2.05 Score on a scale Standard Deviation 3.716
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 49	-4.68 Score on a scale Standard Deviation 2.893	-2.80 Score on a scale Standard Deviation 3.230	-2.27 Score on a scale Standard Deviation 3.139	-2.66 Score on a scale Standard Deviation 2.610	-2.02 Score on a scale Standard Deviation 2.909	-2.02 Score on a scale Standard Deviation 2.625	-3.65 Score on a scale Standard Deviation 1.938	-2.46 Score on a scale Standard Deviation 2.847	-2.06 Score on a scale Standard Deviation 3.875
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 50	-4.56 Score on a scale Standard Deviation 2.923	-2.78 Score on a scale Standard Deviation 3.223	-2.23 Score on a scale Standard Deviation 3.218	-2.44 Score on a scale Standard Deviation 2.699	-1.90 Score on a scale Standard Deviation 2.913	-1.87 Score on a scale Standard Deviation 2.596	-3.78 Score on a scale Standard Deviation 2.092	-2.35 Score on a scale Standard Deviation 2.788	-2.16 Score on a scale Standard Deviation 3.870
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 51	-4.64 Score on a scale Standard Deviation 3.094	-2.67 Score on a scale Standard Deviation 3.188	-2.42 Score on a scale Standard Deviation 3.317	-2.39 Score on a scale Standard Deviation 2.399	-1.80 Score on a scale Standard Deviation 2.860	-1.89 Score on a scale Standard Deviation 2.692	-3.66 Score on a scale Standard Deviation 2.014	-2.40 Score on a scale Standard Deviation 2.777	-2.12 Score on a scale Standard Deviation 3.883
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 52	-4.74 Score on a scale Standard Deviation 2.909	-2.70 Score on a scale Standard Deviation 3.119	-2.17 Score on a scale Standard Deviation 3.152	-2.53 Score on a scale Standard Deviation 2.917	-1.84 Score on a scale Standard Deviation 2.779	-1.84 Score on a scale Standard Deviation 2.929	-3.86 Score on a scale Standard Deviation 2.135	-2.33 Score on a scale Standard Deviation 2.811	-2.12 Score on a scale Standard Deviation 3.904

SECONDARY outcome

Timeframe: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 1	-3.70 Percentage of change Standard Deviation 16.432	-6.26 Percentage of change Standard Deviation 16.312	-7.25 Percentage of change Standard Deviation 13.575	-6.18 Percentage of change Standard Deviation 13.809	-6.05 Percentage of change Standard Deviation 13.049	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 2	-5.63 Percentage of change Standard Deviation 15.340	-7.50 Percentage of change Standard Deviation 20.644	-10.37 Percentage of change Standard Deviation 19.307	-9.86 Percentage of change Standard Deviation 14.734	-11.20 Percentage of change Standard Deviation 18.124	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 3	-7.89 Percentage of change Standard Deviation 22.004	-11.08 Percentage of change Standard Deviation 24.712	-12.11 Percentage of change Standard Deviation 18.977	-14.11 Percentage of change Standard Deviation 17.784	-12.08 Percentage of change Standard Deviation 22.244	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 4	-9.83 Percentage of change Standard Deviation 24.266	-12.16 Percentage of change Standard Deviation 25.287	-16.73 Percentage of change Standard Deviation 22.997	-18.37 Percentage of change Standard Deviation 19.932	-14.95 Percentage of change Standard Deviation 24.356	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 5	-10.14 Percentage of change Standard Deviation 29.071	-12.58 Percentage of change Standard Deviation 27.613	-18.64 Percentage of change Standard Deviation 23.725	-19.20 Percentage of change Standard Deviation 21.900	-20.17 Percentage of change Standard Deviation 25.112	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 6	-12.43 Percentage of change Standard Deviation 27.184	-13.73 Percentage of change Standard Deviation 25.374	-17.59 Percentage of change Standard Deviation 25.814	-18.68 Percentage of change Standard Deviation 22.790	-21.29 Percentage of change Standard Deviation 28.179	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 7	-10.18 Percentage of change Standard Deviation 28.308	-15.89 Percentage of change Standard Deviation 28.992	-20.18 Percentage of change Standard Deviation 25.476	-21.18 Percentage of change Standard Deviation 23.816	-24.03 Percentage of change Standard Deviation 27.650	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 8	-10.51 Percentage of change Standard Deviation 29.803	-18.41 Percentage of change Standard Deviation 31.375	-19.99 Percentage of change Standard Deviation 24.992	-21.14 Percentage of change Standard Deviation 24.981	-26.10 Percentage of change Standard Deviation 27.810	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 9	-13.34 Percentage of change Standard Deviation 32.225	-18.83 Percentage of change Standard Deviation 32.003	-20.36 Percentage of change Standard Deviation 25.407	-25.45 Percentage of change Standard Deviation 24.895	-29.18 Percentage of change Standard Deviation 27.455	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 10	-12.99 Percentage of change Standard Deviation 33.194	-21.19 Percentage of change Standard Deviation 32.110	-22.53 Percentage of change Standard Deviation 25.815	-24.46 Percentage of change Standard Deviation 28.280	-29.43 Percentage of change Standard Deviation 28.109	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 11	-12.73 Percentage of change Standard Deviation 31.638	-21.93 Percentage of change Standard Deviation 31.966	-22.37 Percentage of change Standard Deviation 26.321	-27.67 Percentage of change Standard Deviation 28.079	-31.26 Percentage of change Standard Deviation 29.641	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 12	-10.62 Percentage of change Standard Deviation 32.707	-22.59 Percentage of change Standard Deviation 32.927	-22.05 Percentage of change Standard Deviation 28.445	-26.52 Percentage of change Standard Deviation 28.426	-31.23 Percentage of change Standard Deviation 30.323	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 13	-10.05 Percentage of change Standard Deviation 32.122	-23.88 Percentage of change Standard Deviation 33.561	-24.71 Percentage of change Standard Deviation 30.761	-28.18 Percentage of change Standard Deviation 29.401	-31.36 Percentage of change Standard Deviation 31.724	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 14	-7.60 Percentage of change Standard Deviation 31.351	-23.87 Percentage of change Standard Deviation 34.926	-26.45 Percentage of change Standard Deviation 32.870	-29.19 Percentage of change Standard Deviation 30.904	-32.57 Percentage of change Standard Deviation 31.719	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 15	-6.87 Percentage of change Standard Deviation 29.583	-24.40 Percentage of change Standard Deviation 34.899	-27.46 Percentage of change Standard Deviation 33.838	-28.87 Percentage of change Standard Deviation 31.207	-32.01 Percentage of change Standard Deviation 30.980	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 16	-6.62 Percentage of change Standard Deviation 30.591	-26.85 Percentage of change Standard Deviation 36.332	-27.92 Percentage of change Standard Deviation 33.619	-30.75 Percentage of change Standard Deviation 30.460	-31.97 Percentage of change Standard Deviation 31.194	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 17	-7.46 Percentage of change Standard Deviation 31.529	-27.81 Percentage of change Standard Deviation 35.262	-29.27 Percentage of change Standard Deviation 33.331	-29.68 Percentage of change Standard Deviation 31.753	-32.60 Percentage of change Standard Deviation 31.851	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 18	-6.37 Percentage of change Standard Deviation 31.752	-28.78 Percentage of change Standard Deviation 36.738	-29.49 Percentage of change Standard Deviation 34.514	-29.89 Percentage of change Standard Deviation 31.200	-32.50 Percentage of change Standard Deviation 32.096	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 19	-9.50 Percentage of change Standard Deviation 33.411	-28.98 Percentage of change Standard Deviation 36.372	-29.78 Percentage of change Standard Deviation 35.087	-29.83 Percentage of change Standard Deviation 31.632	-32.77 Percentage of change Standard Deviation 33.698	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 20	-8.56 Percentage of change Standard Deviation 32.725	-30.61 Percentage of change Standard Deviation 37.215	-29.30 Percentage of change Standard Deviation 34.365	-29.48 Percentage of change Standard Deviation 32.361	-31.85 Percentage of change Standard Deviation 32.767	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 21	-9.71 Percentage of change Standard Deviation 34.201	-30.40 Percentage of change Standard Deviation 36.928	-29.63 Percentage of change Standard Deviation 34.869	-31.61 Percentage of change Standard Deviation 32.551	-33.20 Percentage of change Standard Deviation 33.098	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 22	-9.36 Percentage of change Standard Deviation 34.161	-31.81 Percentage of change Standard Deviation 38.100	-30.35 Percentage of change Standard Deviation 36.881	-31.15 Percentage of change Standard Deviation 33.763	-33.28 Percentage of change Standard Deviation 32.108	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 23	-7.23 Percentage of change Standard Deviation 32.486	-34.26 Percentage of change Standard Deviation 38.693	-30.30 Percentage of change Standard Deviation 35.236	-30.52 Percentage of change Standard Deviation 35.354	-35.25 Percentage of change Standard Deviation 33.102	—	—	—	—
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) Week 24	-6.66 Percentage of change Standard Deviation 32.550	-34.70 Percentage of change Standard Deviation 38.656	-30.44 Percentage of change Standard Deviation 36.696	-30.64 Percentage of change Standard Deviation 36.647	-33.26 Percentage of change Standard Deviation 32.433	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 35	-61.70 Percentage of change Standard Deviation 32.381	-46.67 Percentage of change Standard Deviation 36.047	-33.99 Percentage of change Standard Deviation 48.416	-40.21 Percentage of change Standard Deviation 32.239	-18.51 Percentage of change Standard Deviation 37.670	-44.99 Percentage of change Standard Deviation 37.080	-58.12 Percentage of change Standard Deviation 24.772	-36.74 Percentage of change Standard Deviation 37.592	-27.11 Percentage of change Standard Deviation 48.897
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 36	-62.54 Percentage of change Standard Deviation 31.831	-46.63 Percentage of change Standard Deviation 36.326	-33.43 Percentage of change Standard Deviation 48.720	-36.23 Percentage of change Standard Deviation 33.872	-22.43 Percentage of change Standard Deviation 37.322	-43.37 Percentage of change Standard Deviation 37.251	-52.78 Percentage of change Standard Deviation 22.120	-33.66 Percentage of change Standard Deviation 38.520	-22.57 Percentage of change Standard Deviation 47.897
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 37	-60.49 Percentage of change Standard Deviation 31.510	-45.95 Percentage of change Standard Deviation 35.161	-34.42 Percentage of change Standard Deviation 48.542	-32.60 Percentage of change Standard Deviation 31.909	-25.63 Percentage of change Standard Deviation 39.489	-46.52 Percentage of change Standard Deviation 37.336	-58.05 Percentage of change Standard Deviation 27.565	-33.22 Percentage of change Standard Deviation 38.367	-22.63 Percentage of change Standard Deviation 48.038
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 47	-59.01 Percentage of change Standard Deviation 35.211	-40.77 Percentage of change Standard Deviation 44.580	-31.88 Percentage of change Standard Deviation 48.778	-25.60 Percentage of change Standard Deviation 30.211	-25.44 Percentage of change Standard Deviation 39.798	-33.49 Percentage of change Standard Deviation 39.386	-48.45 Percentage of change Standard Deviation 30.519	-33.71 Percentage of change Standard Deviation 38.282	-25.86 Percentage of change Standard Deviation 54.094
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 48	-61.01 Percentage of change Standard Deviation 35.650	-36.53 Percentage of change Standard Deviation 44.443	-33.50 Percentage of change Standard Deviation 48.912	-30.33 Percentage of change Standard Deviation 30.351	-25.04 Percentage of change Standard Deviation 38.230	-29.89 Percentage of change Standard Deviation 38.681	-51.75 Percentage of change Standard Deviation 30.214	-33.16 Percentage of change Standard Deviation 40.239	-29.29 Percentage of change Standard Deviation 53.432
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 49	-61.21 Percentage of change Standard Deviation 35.897	-36.35 Percentage of change Standard Deviation 44.233	-31.23 Percentage of change Standard Deviation 48.493	-34.64 Percentage of change Standard Deviation 34.631	-28.21 Percentage of change Standard Deviation 41.352	-29.37 Percentage of change Standard Deviation 38.374	-48.17 Percentage of change Standard Deviation 27.760	-34.32 Percentage of change Standard Deviation 41.018	-29.80 Percentage of change Standard Deviation 55.717
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 50	-59.59 Percentage of change Standard Deviation 36.330	-36.14 Percentage of change Standard Deviation 44.279	-31.62 Percentage of change Standard Deviation 50.758	-32.01 Percentage of change Standard Deviation 36.290	-26.10 Percentage of change Standard Deviation 40.637	-27.45 Percentage of change Standard Deviation 38.441	-50.18 Percentage of change Standard Deviation 30.773	-32.86 Percentage of change Standard Deviation 40.330	-31.15 Percentage of change Standard Deviation 55.571
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 51	-60.72 Percentage of change Standard Deviation 38.664	-34.31 Percentage of change Standard Deviation 43.008	-34.07 Percentage of change Standard Deviation 51.575	-30.83 Percentage of change Standard Deviation 31.211	-24.47 Percentage of change Standard Deviation 39.779	-27.10 Percentage of change Standard Deviation 39.790	-48.66 Percentage of change Standard Deviation 29.191	-33.72 Percentage of change Standard Deviation 40.790	-30.75 Percentage of change Standard Deviation 55.841
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 52	-61.83 Percentage of change Standard Deviation 35.861	-35.06 Percentage of change Standard Deviation 42.961	-30.54 Percentage of change Standard Deviation 49.791	-33.29 Percentage of change Standard Deviation 38.191	-25.37 Percentage of change Standard Deviation 39.165	-25.94 Percentage of change Standard Deviation 43.683	-50.89 Percentage of change Standard Deviation 29.752	-32.36 Percentage of change Standard Deviation 40.612	-30.50 Percentage of change Standard Deviation 56.024
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 34	-59.41 Percentage of change Standard Deviation 29.414	-47.09 Percentage of change Standard Deviation 35.098	-30.56 Percentage of change Standard Deviation 48.227	-43.33 Percentage of change Standard Deviation 34.277	-17.18 Percentage of change Standard Deviation 39.855	-42.96 Percentage of change Standard Deviation 37.718	-50.34 Percentage of change Standard Deviation 22.937	-35.63 Percentage of change Standard Deviation 37.586	-27.22 Percentage of change Standard Deviation 51.629
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 24	-56.60 Percentage of change Standard Deviation 24.568	-49.61 Percentage of change Standard Deviation 33.036	-38.71 Percentage of change Standard Deviation 44.259	-52.36 Percentage of change Standard Deviation 33.258	-29.76 Percentage of change Standard Deviation 40.611	-42.27 Percentage of change Standard Deviation 36.685	-59.49 Percentage of change Standard Deviation 22.140	-38.95 Percentage of change Standard Deviation 34.963	-29.09 Percentage of change Standard Deviation 44.653
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 25	-54.31 Percentage of change Standard Deviation 29.223	-52.15 Percentage of change Standard Deviation 31.579	-36.78 Percentage of change Standard Deviation 45.402	-53.26 Percentage of change Standard Deviation 33.810	-31.69 Percentage of change Standard Deviation 40.647	-41.26 Percentage of change Standard Deviation 34.643	-63.84 Percentage of change Standard Deviation 23.417	-37.04 Percentage of change Standard Deviation 36.046	-30.81 Percentage of change Standard Deviation 46.001
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 26	-50.31 Percentage of change Standard Deviation 29.134	-51.62 Percentage of change Standard Deviation 32.197	-36.84 Percentage of change Standard Deviation 44.342	-48.88 Percentage of change Standard Deviation 32.071	-30.68 Percentage of change Standard Deviation 42.883	-38.14 Percentage of change Standard Deviation 35.393	-57.52 Percentage of change Standard Deviation 22.280	-37.71 Percentage of change Standard Deviation 37.451	-28.48 Percentage of change Standard Deviation 46.252
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 27	-53.62 Percentage of change Standard Deviation 30.255	-52.09 Percentage of change Standard Deviation 32.613	-35.34 Percentage of change Standard Deviation 44.056	-47.36 Percentage of change Standard Deviation 30.909	-29.42 Percentage of change Standard Deviation 40.379	-42.65 Percentage of change Standard Deviation 36.665	-57.00 Percentage of change Standard Deviation 20.810	-35.32 Percentage of change Standard Deviation 38.963	-29.92 Percentage of change Standard Deviation 48.506
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 28	-53.08 Percentage of change Standard Deviation 30.684	-52.36 Percentage of change Standard Deviation 32.642	-34.80 Percentage of change Standard Deviation 45.063	-47.19 Percentage of change Standard Deviation 31.551	-30.58 Percentage of change Standard Deviation 38.398	-44.86 Percentage of change Standard Deviation 36.493	-56.28 Percentage of change Standard Deviation 24.247	-38.37 Percentage of change Standard Deviation 38.703	-27.74 Percentage of change Standard Deviation 49.936
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 29	-54.93 Percentage of change Standard Deviation 28.705	-50.48 Percentage of change Standard Deviation 35.634	-34.13 Percentage of change Standard Deviation 44.735	-50.29 Percentage of change Standard Deviation 29.286	-24.35 Percentage of change Standard Deviation 38.746	-44.31 Percentage of change Standard Deviation 37.579	-56.79 Percentage of change Standard Deviation 23.453	-36.46 Percentage of change Standard Deviation 38.211	-26.40 Percentage of change Standard Deviation 48.994
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 30	-58.70 Percentage of change Standard Deviation 30.600	-44.79 Percentage of change Standard Deviation 34.219	-37.91 Percentage of change Standard Deviation 46.288	-49.35 Percentage of change Standard Deviation 28.435	-28.00 Percentage of change Standard Deviation 35.916	-40.30 Percentage of change Standard Deviation 37.098	-48.05 Percentage of change Standard Deviation 24.892	-36.03 Percentage of change Standard Deviation 38.742	-26.58 Percentage of change Standard Deviation 49.832
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 31	-55.77 Percentage of change Standard Deviation 30.420	-46.03 Percentage of change Standard Deviation 34.355	-37.18 Percentage of change Standard Deviation 49.311	-49.01 Percentage of change Standard Deviation 28.581	-21.78 Percentage of change Standard Deviation 41.439	-42.26 Percentage of change Standard Deviation 39.161	-52.67 Percentage of change Standard Deviation 29.311	-39.45 Percentage of change Standard Deviation 38.697	-21.51 Percentage of change Standard Deviation 44.331
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 32	-57.32 Percentage of change Standard Deviation 29.140	-46.40 Percentage of change Standard Deviation 35.233	-34.68 Percentage of change Standard Deviation 47.719	-40.69 Percentage of change Standard Deviation 34.523	-19.61 Percentage of change Standard Deviation 37.935	-42.64 Percentage of change Standard Deviation 38.113	-56.51 Percentage of change Standard Deviation 27.668	-37.63 Percentage of change Standard Deviation 38.453	-22.64 Percentage of change Standard Deviation 46.122
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 33	-57.76 Percentage of change Standard Deviation 29.406	-48.66 Percentage of change Standard Deviation 36.625	-33.52 Percentage of change Standard Deviation 48.881	-39.31 Percentage of change Standard Deviation 33.036	-24.61 Percentage of change Standard Deviation 39.502	-42.45 Percentage of change Standard Deviation 38.100	-52.89 Percentage of change Standard Deviation 22.337	-37.50 Percentage of change Standard Deviation 39.368	-21.49 Percentage of change Standard Deviation 48.348
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 38	-60.83 Percentage of change Standard Deviation 31.559	-43.12 Percentage of change Standard Deviation 42.814	-31.62 Percentage of change Standard Deviation 47.534	-26.80 Percentage of change Standard Deviation 31.244	-24.20 Percentage of change Standard Deviation 40.063	-47.17 Percentage of change Standard Deviation 39.147	-58.43 Percentage of change Standard Deviation 27.410	-33.72 Percentage of change Standard Deviation 37.516	-24.07 Percentage of change Standard Deviation 49.645
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 39	-56.79 Percentage of change Standard Deviation 31.763	-43.54 Percentage of change Standard Deviation 42.937	-31.75 Percentage of change Standard Deviation 48.313	-32.75 Percentage of change Standard Deviation 31.185	-25.49 Percentage of change Standard Deviation 40.126	-46.10 Percentage of change Standard Deviation 38.082	-59.36 Percentage of change Standard Deviation 25.162	-32.70 Percentage of change Standard Deviation 38.945	-25.98 Percentage of change Standard Deviation 48.229
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 40	-56.78 Percentage of change Standard Deviation 31.397	-42.94 Percentage of change Standard Deviation 43.748	-30.52 Percentage of change Standard Deviation 48.657	-27.37 Percentage of change Standard Deviation 25.233	-24.24 Percentage of change Standard Deviation 38.972	-43.62 Percentage of change Standard Deviation 38.048	-38.57 Percentage of change Standard Deviation 22.074	-34.20 Percentage of change Standard Deviation 39.168	-24.22 Percentage of change Standard Deviation 49.044
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 41	-61.18 Percentage of change Standard Deviation 30.487	-42.33 Percentage of change Standard Deviation 43.065	-30.85 Percentage of change Standard Deviation 48.900	-22.99 Percentage of change Standard Deviation 23.218	-27.38 Percentage of change Standard Deviation 39.966	-39.66 Percentage of change Standard Deviation 42.054	-47.95 Percentage of change Standard Deviation 26.092	-34.51 Percentage of change Standard Deviation 40.123	-24.13 Percentage of change Standard Deviation 55.219
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 42	-62.53 Percentage of change Standard Deviation 32.149	-41.68 Percentage of change Standard Deviation 42.874	-30.76 Percentage of change Standard Deviation 50.332	-34.23 Percentage of change Standard Deviation 35.319	-26.33 Percentage of change Standard Deviation 40.513	-42.91 Percentage of change Standard Deviation 42.866	-49.33 Percentage of change Standard Deviation 29.448	-32.01 Percentage of change Standard Deviation 39.405	-29.48 Percentage of change Standard Deviation 53.423
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 43	-62.27 Percentage of change Standard Deviation 36.647	-42.86 Percentage of change Standard Deviation 43.495	-30.51 Percentage of change Standard Deviation 48.200	-33.86 Percentage of change Standard Deviation 33.053	-23.93 Percentage of change Standard Deviation 40.455	-41.66 Percentage of change Standard Deviation 38.115	-48.09 Percentage of change Standard Deviation 26.148	-31.34 Percentage of change Standard Deviation 41.919	-33.70 Percentage of change Standard Deviation 54.865
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 44	-64.61 Percentage of change Standard Deviation 31.787	-43.47 Percentage of change Standard Deviation 44.000	-31.71 Percentage of change Standard Deviation 49.607	-31.76 Percentage of change Standard Deviation 30.960	-24.67 Percentage of change Standard Deviation 37.725	-42.36 Percentage of change Standard Deviation 40.085	-46.04 Percentage of change Standard Deviation 28.399	-31.28 Percentage of change Standard Deviation 40.103	-29.07 Percentage of change Standard Deviation 53.672
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 45	-61.59 Percentage of change Standard Deviation 33.745	-47.27 Percentage of change Standard Deviation 40.996	-33.33 Percentage of change Standard Deviation 50.319	-25.91 Percentage of change Standard Deviation 26.492	-25.91 Percentage of change Standard Deviation 38.680	-39.63 Percentage of change Standard Deviation 39.211	-47.19 Percentage of change Standard Deviation 28.645	-31.41 Percentage of change Standard Deviation 39.716	-27.07 Percentage of change Standard Deviation 54.016
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) Week 46	-58.81 Percentage of change Standard Deviation 35.801	-42.11 Percentage of change Standard Deviation 45.119	-33.68 Percentage of change Standard Deviation 49.356	-34.27 Percentage of change Standard Deviation 33.932	-25.58 Percentage of change Standard Deviation 38.019	-34.77 Percentage of change Standard Deviation 38.757	-49.76 Percentage of change Standard Deviation 30.190	-31.98 Percentage of change Standard Deviation 39.640	-28.89 Percentage of change Standard Deviation 58.573

SECONDARY outcome

Timeframe: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Outcome measures

Measure	Placebo (Part 1) n=79 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=79 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 1	1.3 Percentage of participants	2.6 Percentage of participants	1.3 Percentage of participants	1.3 Percentage of participants	1.3 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 2	2.5 Percentage of participants	3.9 Percentage of participants	6.4 Percentage of participants	1.3 Percentage of participants	6.3 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 3	6.3 Percentage of participants	9.1 Percentage of participants	6.4 Percentage of participants	10.4 Percentage of participants	7.6 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 4	7.6 Percentage of participants	10.4 Percentage of participants	14.1 Percentage of participants	15.6 Percentage of participants	13.9 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 5	11.4 Percentage of participants	15.6 Percentage of participants	15.4 Percentage of participants	16.9 Percentage of participants	19.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 6	12.7 Percentage of participants	10.4 Percentage of participants	19.2 Percentage of participants	18.2 Percentage of participants	21.5 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 7	11.4 Percentage of participants	16.9 Percentage of participants	23.1 Percentage of participants	20.8 Percentage of participants	25.3 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 8	15.2 Percentage of participants	22.1 Percentage of participants	17.9 Percentage of participants	22.1 Percentage of participants	26.6 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 9	13.9 Percentage of participants	20.8 Percentage of participants	19.2 Percentage of participants	27.3 Percentage of participants	31.6 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 10	15.2 Percentage of participants	27.3 Percentage of participants	23.1 Percentage of participants	28.6 Percentage of participants	38.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 11	13.9 Percentage of participants	26.0 Percentage of participants	23.1 Percentage of participants	31.2 Percentage of participants	36.7 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 12	16.5 Percentage of participants	26.0 Percentage of participants	20.5 Percentage of participants	28.6 Percentage of participants	38.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 13	13.9 Percentage of participants	28.6 Percentage of participants	26.9 Percentage of participants	29.9 Percentage of participants	38.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 14	13.9 Percentage of participants	35.1 Percentage of participants	29.5 Percentage of participants	28.6 Percentage of participants	40.5 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 15	10.1 Percentage of participants	29.9 Percentage of participants	28.2 Percentage of participants	28.6 Percentage of participants	40.5 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 16	10.1 Percentage of participants	32.5 Percentage of participants	33.3 Percentage of participants	29.9 Percentage of participants	41.8 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 17	13.9 Percentage of participants	32.5 Percentage of participants	30.8 Percentage of participants	27.3 Percentage of participants	38.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 18	12.7 Percentage of participants	36.4 Percentage of participants	33.3 Percentage of participants	29.9 Percentage of participants	43.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 19	15.2 Percentage of participants	35.1 Percentage of participants	32.1 Percentage of participants	33.8 Percentage of participants	43.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 20	10.1 Percentage of participants	33.8 Percentage of participants	30.8 Percentage of participants	31.2 Percentage of participants	36.7 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 21	15.2 Percentage of participants	37.7 Percentage of participants	32.1 Percentage of participants	33.8 Percentage of participants	36.7 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 22	13.9 Percentage of participants	37.7 Percentage of participants	30.8 Percentage of participants	33.8 Percentage of participants	39.2 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 23	12.7 Percentage of participants	41.6 Percentage of participants	35.9 Percentage of participants	37.7 Percentage of participants	43.0 Percentage of participants	—	—	—	—
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) Week 24	11.4 Percentage of participants	40.3 Percentage of participants	30.8 Percentage of participants	36.4 Percentage of participants	39.2 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 24 to week 52

Population: Participants who reached EASI 50 at week 24 and re-randomized participants at week 24.

The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Incidence Rate of Loss of EASI 50 (Part 2)	0.165 Events per patient-year	0 Events per patient-year	0.272 Events per patient-year	0.188 Events per patient-year	0.089 Events per patient-year	0.071 Events per patient-year	0 Events per patient-year	0.193 Events per patient-year	0.145 Events per patient-year

SECONDARY outcome

Timeframe: Week 24 to week 52

Population: Participants who reached EASI 75 at week 24 and re-randomized participants at week 24.

The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.

Outcome measures

Measure	Placebo (Part 1) n=11 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=12 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=27 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Incidence Rate of Loss of EASI 75 (Part 2)	0.395 Events per patient-year	0 Events per patient-year	0.587 Events per patient-year	0.375 Events per patient-year	0.486 Events per patient-year	0.446 Events per patient-year	0.351 Events per patient-year	0.573 Events per patient-year	0.646 Events per patient-year

SECONDARY outcome

Timeframe: Week 24 to week 68

Population: Participants who had IGA response 0 or 1 at week 24 and re-randomized at week 24.

The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=12 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=35 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=16 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Incidence Rate of Loss of IGA 0/1 (Part 2)	1.154 Events per patient-year	1.267 Events per patient-year	1.039 Events per patient-year	0.981 Events per patient-year	1.930 Events per patient-year	1.045 Events per patient-year	1.096 Events per patient-year	1.790 Events per patient-year	0.244 Events per patient-year

SECONDARY outcome

Timeframe: Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24

Population: This analysis was conducted for Part 1 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported.

Outcome measures

Measure	Placebo (Part 1) Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=76 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Baseline	—	0.00 (ug/ml) Standard Deviation 0.014	0.00 (ug/ml) Standard Deviation 0.014	0.01 (ug/ml) Standard Deviation 0.074	0.00 (ug/ml) Standard Deviation 0.000	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 1	—	58.29 (ug/ml) Standard Deviation 24.674	30.49 (ug/ml) Standard Deviation 18.520	14.18 (ug/ml) Standard Deviation 5.060	8.49 (ug/ml) Standard Deviation 3.331	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 2	—	47.56 (ug/ml) Standard Deviation 17.274	25.09 (ug/ml) Standard Deviation 9.041	13.56 (ug/ml) Standard Deviation 3.886	7.57 (ug/ml) Standard Deviation 2.947	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 4	—	38.49 (ug/ml) Standard Deviation 22.532	19.00 (ug/ml) Standard Deviation 7.869	9.67 (ug/ml) Standard Deviation 3.728	5.09 (ug/ml) Standard Deviation 2.176	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 8	—	37.67 (ug/ml) Standard Deviation 15.157	32.14 (ug/ml) Standard Deviation 16.502	15.07 (ug/ml) Standard Deviation 6.383	7.92 (ug/ml) Standard Deviation 3.263	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 12	—	39.26 (ug/ml) Standard Deviation 33.847	34.67 (ug/ml) Standard Deviation 15.191	18.12 (ug/ml) Standard Deviation 8.439	9.22 (ug/ml) Standard Deviation 4.116	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 16	—	40.12 (ug/ml) Standard Deviation 28.610	38.09 (ug/ml) Standard Deviation 13.536	18.39 (ug/ml) Standard Deviation 7.245	10.13 (ug/ml) Standard Deviation 4.515	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 17	—	62.34 (ug/ml) Standard Deviation 28.081	64.64 (ug/ml) Standard Deviation 24.169	29.26 (ug/ml) Standard Deviation 11.659	16.79 (ug/ml) Standard Deviation 6.677	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 20	—	37.92 (ug/ml) Standard Deviation 14.171	48.26 (ug/ml) Standard Deviation 30.691	19.31 (ug/ml) Standard Deviation 7.203	10.68 (ug/ml) Standard Deviation 3.715	—	—	—	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 1) Week 24	—	41.98 (ug/ml) Standard Deviation 23.087	43.81 (ug/ml) Standard Deviation 17.403	20.25 (ug/ml) Standard Deviation 10.575	11.07 (ug/ml) Standard Deviation 3.918	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52

Population: This analysis was conducted for Part 2 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=11 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=31 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 24	19.03 (ug/ml) Standard Deviation 9.612	45.13 (ug/ml) Standard Deviation 15.842	36.68 (ug/ml) Standard Deviation 17.544	45.00 (ug/ml) Standard Deviation 14.568	43.17 (ug/ml) Standard Deviation 19.752	19.48 (ug/ml) Standard Deviation 7.791	11.60 (ug/ml) Standard Deviation 1.383	11.10 (ug/ml) Standard Deviation 5.240	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 25	31.07 (ug/ml) Standard Deviation 16.115	73.54 (ug/ml) Standard Deviation 30.680	36.54 (ug/ml) Standard Deviation 20.508	71.25 (ug/ml) Standard Deviation 16.294	34.71 (ug/ml) Standard Deviation 14.551	17.57 (ug/ml) Standard Deviation 7.504	15.90 (ug/ml) Standard Deviation 2.443	10.36 (ug/ml) Standard Deviation 5.145	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 28	20.12 (ug/ml) Standard Deviation 11.820	51.50 (ug/ml) Standard Deviation 25.454	17.59 (ug/ml) Standard Deviation 9.090	46.15 (ug/ml) Standard Deviation 15.782	25.22 (ug/ml) Standard Deviation 10.235	10.03 (ug/ml) Standard Deviation 4.697	9.56 (ug/ml) Standard Deviation 3.485	6.66 (ug/ml) Standard Deviation 2.584	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 32	20.99 (ug/ml) Standard Deviation 12.614	44.41 (ug/ml) Standard Deviation 11.438	8.86 (ug/ml) Standard Deviation 5.074	41.50 (ug/ml) Standard Deviation 13.681	12.54 (ug/ml) Standard Deviation 5.943	4.57 (ug/ml) Standard Deviation 2.463	9.40 (ug/ml) Standard Deviation 1.749	3.32 (ug/ml) Standard Deviation 1.588	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 36	22.28 (ug/ml) Standard Deviation 18.101	43.11 (ug/ml) Standard Deviation 18.965	5.41 (ug/ml) Standard Deviation 3.876	51.42 (ug/ml) Standard Deviation 18.946	7.80 (ug/ml) Standard Deviation 4.413	2.85 (ug/ml) Standard Deviation 2.275	13.38 (ug/ml) Standard Deviation 2.128	1.77 (ug/ml) Standard Deviation 1.018	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 40	19.09 (ug/ml) Standard Deviation 11.479	45.19 (ug/ml) Standard Deviation 19.921	2.42 (ug/ml) Standard Deviation 1.660	43.79 (ug/ml) Standard Deviation 15.955	4.54 (ug/ml) Standard Deviation 2.929	1.68 (ug/ml) Standard Deviation 1.669	10.95 (ug/ml) Standard Deviation 1.350	0.96 (ug/ml) Standard Deviation 0.748	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 44	16.43 (ug/ml) Standard Deviation 7.302	40.91 (ug/ml) Standard Deviation 12.068	1.04 (ug/ml) Standard Deviation 0.908	46.98 (ug/ml) Standard Deviation 24.015	2.62 (ug/ml) Standard Deviation 2.193	0.82 (ug/ml) Standard Deviation 0.863	11.25 (ug/ml) Standard Deviation 2.607	0.57 (ug/ml) Standard Deviation 0.554	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 48	17.80 (ug/ml) Standard Deviation 9.065	41.43 (ug/ml) Standard Deviation 14.214	0.58 (ug/ml) Standard Deviation 0.507	43.63 (ug/ml) Standard Deviation 22.188	1.40 (ug/ml) Standard Deviation 1.727	0.42 (ug/ml) Standard Deviation 0.483	11.12 (ug/ml) Standard Deviation 1.825	0.25 (ug/ml) Standard Deviation 0.305	—
Serum KY1005 Concentration Assessed Throughout the Study (Part 2) Week 52	22.60 (ug/ml) Standard Deviation 8.225	38.88 (ug/ml) Standard Deviation 11.526	0.56 (ug/ml) Standard Deviation 1.112	45.59 (ug/ml) Standard Deviation 22.447	0.55 (ug/ml) Standard Deviation 0.573	0.19 (ug/ml) Standard Deviation 0.289	12.03 (ug/ml) Standard Deviation 3.775	0.11 (ug/ml) Standard Deviation 0.129	—

SECONDARY outcome

Timeframe: Baseline through week 24

Population: Safety Analysis Part 1:Participants who took at least a dose of study treatment, including placebo up to Week 24. Analysis based on the SAF1 was based on the treatment received, regardless of assigned treatment according to the randomization

Outcome measures

Measure	Placebo (Part 1) n=78 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=78 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) Any Treatment Emergent Adverse Event	60.3 Percentage of participants	66.2 Percentage of participants	66.7 Percentage of participants	67.5 Percentage of participants	67.9 Percentage of participants	—	—	—	—
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) Any Serious Treatment Emergent Adverse Event	1.3 Percentage of participants	2.6 Percentage of participants	0 Percentage of participants	1.3 Percentage of participants	6.4 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 24 through week 68

Population: Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least a dose of study treatment on/or after Week 24. Any analysis based on the SAF2 was based on the treatment at Week 24, regardless of treatment according to the randomization.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=11 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=32 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=34 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo n=15 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) Any Treatment Emergent Adverse Event	66.7 Percentage of participants	84.6 Percentage of participants	67.6 Percentage of participants	63.6 Percentage of participants	78.6 Percentage of participants	87.5 Percentage of participants	57.1 Percentage of participants	67.6 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) Any Serious Treatment Emergent Adverse Event	8.3 Percentage of participants	7.7 Percentage of participants	2.9 Percentage of participants	0 Percentage of participants	7.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline through week 24

Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24.

Outcome measures

Measure	Placebo (Part 1) Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=77 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=76 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=77 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With Treatment-emergent ADA (Part 1)	—	2.6 Percentage of participants	6.4 Percentage of participants	13.2 Percentage of participants	32.1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline through week 68

Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24.

Outcome measures

Measure	Placebo (Part 1) n=12 Participants Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg (500 mg LD) KY1005 (Part 1) n=13 Participants Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=11 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=26 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=31 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=33 Participants Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) Continued From Part 1 Placebo Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Percentage of Participants With Treatment-emergent ADA (Part 2)	0 Percentage of participants	7.7 Percentage of participants	9.1 Percentage of participants	9.1 Percentage of participants	19.2 Percentage of participants	35.5 Percentage of participants	28.6 Percentage of participants	42.4 Percentage of participants	—

Adverse Events

250 mg (500 mg LD) KY1005 (Part 1)

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

250 mg (no LD) KY1005 (Part 1)

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

125 mg KY1005 (Part 1)

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

62.5 mg KY1005 (Part 1)

Serious events: 5 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo (Part 1)

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Re-randomized From the 62.5 mg Arm (Part 2)

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo (Part 2)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	250 mg (500 mg LD) KY1005 (Part 1) n=77 participants at risk Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	250 mg (no LD) KY1005 (Part 1) n=78 participants at risk Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.	125 mg KY1005 (Part 1) n=77 participants at risk Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.	62.5 mg KY1005 (Part 1) n=78 participants at risk Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.	Placebo (Part 1) n=78 participants at risk Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2) n=13 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=11 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2) n=12 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=32 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=34 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) n=15 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Cardiac disorders Atrial fibrillation	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Cardiac disorders Supraventricular tachycardia	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Gastrointestinal disorders Umbilical hernia	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.7% 1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations Appendicitis	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations Pharyngitis	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Metabolism and nutrition disorders Metabolic acidosis	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	— 0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	— 0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	— 0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Nervous system disorders Tension Headache	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	— 0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Psychiatric disorders Alcohol withdrawal syndrome	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	— 0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	— 0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.

Other adverse events

Measure	250 mg (500 mg LD) KY1005 (Part 1) n=77 participants at risk Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.	250 mg (no LD) KY1005 (Part 1) n=78 participants at risk Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.	125 mg KY1005 (Part 1) n=77 participants at risk Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.	62.5 mg KY1005 (Part 1) n=78 participants at risk Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.	Placebo (Part 1) n=78 participants at risk Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2) n=13 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) n=34 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52	250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) n=11 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52	Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) n=28 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2) n=12 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) n=32 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) n=7 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52	Placebo Re-randomized From the 62.5 mg Arm (Part 2) n=34 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52	Placebo (Part 2) n=15 participants at risk Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Gastrointestinal disorders ABDOMINAL PAIN	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.7% 1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.1% 2/28 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Gastrointestinal disorders FOOD POISONING	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
General disorders FATIGUE	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.7% 1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.8% 3/34 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
General disorders INFLUENZA LIKE ILLNESS	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Immune system disorders SEASONAL ALLERGY	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations BRONCHITIS VIRAL	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations COVID-19	7.8% 6/77 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.0% 7/78 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 7/77 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.1% 4/78 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.4% 5/78 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations CYSTITIS	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	14.3% 1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations DERMATITIS INFECTED	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	11.8% 4/34 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations FOLLICULITIS	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations FUNGAL SKIN INFECTION	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations HERPES SIMPLEX	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations INFLUENZA	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations NASOPHARYNGITIS	18.2% 14/77 • Number of events 19 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.7% 6/78 • Number of events 8 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	11.7% 9/77 • Number of events 12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.4% 5/78 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.0% 7/78 • Number of events 10 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	15.4% 2/13 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	11.8% 4/34 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.1% 2/28 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	15.6% 5/32 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.8% 3/34 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	13.3% 2/15 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations ORAL HERPES	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations OTITIS Media	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations PHARYNGITIS	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.1% 2/28 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations POSTOPERATIVE WOUND INFECTION	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations PYURIA	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.7% 1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations RHINITIS	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations SINUSITIS	1.3% 1/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations TONSILLITIS	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.2% 4/77 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.4% 5/78 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.4% 5/78 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.9% 2/34 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.8% 3/34 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	14.3% 1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.8% 3/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.1% 4/78 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	36.4% 4/11 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	13.3% 2/15 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.8% 3/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	14.3% 1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Investigations ALANINE AMINOTRANSFERASE INCREASED	2.6% 2/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	5.2% 4/77 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	14.3% 1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.9% 2/34 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Musculoskeletal and connective tissue disorders BACK PAIN	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	14.3% 1/7 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Musculoskeletal and connective tissue disorders PERIOSTITIS	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Musculoskeletal and connective tissue disorders SPINAL PAIN	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	13.3% 2/15 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Nervous system disorders DIZZINESS	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Nervous system disorders HEADACHE	5.2% 4/77 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.1% 4/78 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.2% 4/77 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.0% 7/78 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.8% 3/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	15.4% 2/13 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	16.7% 2/12 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Nervous system disorders HYPOAESTHESIA	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Nervous system disorders TENSION HEADACHE	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Reproductive system and breast disorders DYSMENORRHOEA	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.9% 2/34 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Reproductive system and breast disorders HEAVY MENSTRUAL BLEEDING	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.6% 1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	3.1% 1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.7% 1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.7% 1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	11.7% 9/77 • Number of events 10 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	20.5% 16/78 • Number of events 22 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	19.5% 15/77 • Number of events 19 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	16.7% 13/78 • Number of events 14 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	38.5% 30/78 • Number of events 43 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	46.2% 6/13 • Number of events 8 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	41.2% 14/34 • Number of events 21 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	27.3% 3/11 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	53.6% 15/28 • Number of events 19 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	8.3% 1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	43.8% 14/32 • Number of events 17 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	14.3% 1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	35.3% 12/34 • Number of events 13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	26.7% 4/15 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Skin and subcutaneous tissue disorders RASH	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	7.7% 1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Skin and subcutaneous tissue disorders ROSACEA	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	9.1% 1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
Vascular disorders HYPERTENSION	2.6% 2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	1.3% 1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	5.1% 4/78 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	2.9% 1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	6.2% 2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.	0.00% 0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: contact-us@saonofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
• Publication restrictions are in place

Restriction type: OTHER