Trial Outcomes & Findings for Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (NCT NCT04589650)

NCT ID: NCT04589650

Last Updated: 2025-12-17

Results Overview

A responder is defined by achieving a \>=20% reduction from baseline in the sum of target lesion volumes (via BIRC), provided that none of the individual target lesions have a \>=20% increase from baseline and in absence of progression of non target lesions and without new lesions. Confirmation of response requires a subsequent imaging assessment performed at least 4 weeks after the onset of response. Participants who permanently discontinued alpelisib prior to confirmation of response, and participants who received surgery as rescue therapy prior to confirmation of response are considered as non-responders.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 203 participants
• Primary outcome timeframe: Up to 48 weeks
• Results posted on: 2025-12-17

Participant Flow

The study is conducted globally across 12 countries. Recruitment in Group 3 will be open after protocol amendment 5 approval in 2025.

Participant milestones

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 1 (Greater or Equal to 18 Years) - Placebo Arm Group 1: During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive placebo (125 mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Group 2 (6-17 Years) - Alpelisib Arm Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Exploratory Group 4 (2-5 Years) All Pediatrics - Alpelisib FCT Pediatric participants (2 to 5 years old) will receive 50 mg of alpelisib film-coated tablets (FCT) once daily in an open-label setting.	Exploratory Group 5 (6-17 Years) All Pediatrics - Alpelisib FCT Pediatric participants (6 to 17 year old) will receive 125 mg alpelisib film-coated (FCT) once daily, in an open-label setting.
Overall Study STARTED	54	27	56	28	7	16
Overall Study Completed Core	52	26	55	26	7	13
Overall Study Completed Extension 1	46	24	55	26	7	4
Overall Study Full Analysis Set (FAS)	54	27	56	28	7	16
Overall Study Full Analysis Set (FAS) - BYL719	54	0	56	0	0	0
Overall Study Safety Set	54	27	56	28	7	16
Overall Study Pharmacokinetic Analysis Set (PAS)	51	25	56	26	7	16
Overall Study COMPLETED	42	23	53	25	7	15
Overall Study NOT COMPLETED	12	4	3	3	0	1

Reasons for withdrawal

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 1 (Greater or Equal to 18 Years) - Placebo Arm Group 1: During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive placebo (125 mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Group 2 (6-17 Years) - Alpelisib Arm Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Exploratory Group 4 (2-5 Years) All Pediatrics - Alpelisib FCT Pediatric participants (2 to 5 years old) will receive 50 mg of alpelisib film-coated tablets (FCT) once daily in an open-label setting.	Exploratory Group 5 (6-17 Years) All Pediatrics - Alpelisib FCT Pediatric participants (6 to 17 year old) will receive 125 mg alpelisib film-coated (FCT) once daily, in an open-label setting.
Overall Study Subject decision	6	2	2	0	0	0
Overall Study Adverse Event	3	1	1	1	0	1
Overall Study Physician Decision	1	1	0	0	0	0
Overall Study Unsatisfactory therapeutic effect	2	0	0	0	0	0
Overall Study Death	0	0	0	1	0	0
Overall Study Guardian Decision	0	0	0	1	0	0

Baseline Characteristics

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

Baseline characteristics by cohort

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=54 Participants Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 1 (Greater or Equal to 18 Years) - Placebo Arm n=27 Participants Group 1: During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive placebo (125 mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Group 2 (6-17 Years) - Alpelisib Arm n=56 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm n=28 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Exploratory Group 4 (2-5 Years) All Pediatrics - Alpelisib FCT n=7 Participants Pediatric participants (2 to 5 years old) will receive 50 mg of alpelisib film-coated tablets (FCT) once daily in an open-label setting.	Exploratory Group 5 (6-17 Years) All Pediatrics - Alpelisib FCT n=16 Participants Pediatric participants (6 to 17 year old) will receive 125 mg alpelisib film-coated (FCT) once daily, in an open-label setting.	Total n=188 Participants Total of all reporting groups
Age, Customized Children, 2 - < 6 years	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	7 Participants n=488 Participants	0 Participants n=182 Participants	7 Participants n=3 Participants
Age, Customized Children, 6 - < 12 years	0 Participants n=6 Participants	0 Participants n=5 Participants	28 Participants n=5 Participants	19 Participants n=122 Participants	0 Participants n=488 Participants	12 Participants n=182 Participants	59 Participants n=3 Participants
Age, Customized Adolescent, 12 - < 18 years	0 Participants n=6 Participants	0 Participants n=5 Participants	28 Participants n=5 Participants	9 Participants n=122 Participants	0 Participants n=488 Participants	4 Participants n=182 Participants	41 Participants n=3 Participants
Age, Customized 18 - < 65 years	54 Participants n=6 Participants	27 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	81 Participants n=3 Participants
Sex: Female, Male Female	34 Participants n=6 Participants	14 Participants n=5 Participants	27 Participants n=5 Participants	12 Participants n=122 Participants	3 Participants n=488 Participants	8 Participants n=182 Participants	98 Participants n=3 Participants
Sex: Female, Male Male	20 Participants n=6 Participants	13 Participants n=5 Participants	29 Participants n=5 Participants	16 Participants n=122 Participants	4 Participants n=488 Participants	8 Participants n=182 Participants	90 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	6 Participants n=6 Participants	3 Participants n=5 Participants	10 Participants n=5 Participants	3 Participants n=122 Participants	0 Participants n=488 Participants	2 Participants n=182 Participants	24 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	2 Participants n=3 Participants
Race (NIH/OMB) White	48 Participants n=6 Participants	22 Participants n=5 Participants	42 Participants n=5 Participants	25 Participants n=122 Participants	7 Participants n=488 Participants	13 Participants n=182 Participants	157 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	1 Participants n=5 Participants	2 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	3 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	1 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	1 Participants n=182 Participants	2 Participants n=3 Participants

PRIMARY outcome

Timeframe: Up to 48 weeks

Population: Full Analysis Set (FAS) - BYL719. All patients to whom alpelisib had been assigned by randomization.

A responder is defined by achieving a >=20% reduction from baseline in the sum of target lesion volumes (via BIRC), provided that none of the individual target lesions have a >=20% increase from baseline and in absence of progression of non target lesions and without new lesions. Confirmation of response requires a subsequent imaging assessment performed at least 4 weeks after the onset of response. Participants who permanently discontinued alpelisib prior to confirmation of response, and participants who received surgery as rescue therapy prior to confirmation of response are considered as non-responders.

Outcome measures

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=54 Participants Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=56 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.
Proportion of Participants Randomized to Alpelisib With a Confirmed Objective Response by BIRC in Group 1 and Group 2	16.7 % of confirmed responder by BIRC Interval 7.0 to 31.1	23.2 % of confirmed responder by BIRC Interval 11.9 to 38.3	—	—

SECONDARY outcome

Timeframe: Week 16

Population: Full Analysis Set (FAS). All patients to whom study treatment was assigned by randomization.

A responder is defined by achieving a >=20% reduction from baseline in the sum of target lesion volumes (via BIRC) at Week 16, provided that none of the individual target lesions have a >=20% increase from baseline and in absence of progression of non-target lesions and without new lesions. Participants who permanently discontinued alpelisib prior to Week 16, participants who received surgery as rescue therapy prior to Week 16, and participants who had a missing/non-evaluable radiological assessment at Week 16 are considered as non-responders.

Outcome measures

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=54 Participants Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=27 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=56 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm n=28 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.
Key Secondary Objective: Proportion of Participants With Response at Week 16 by BIRC in Group 1 and Group 2	11.1 % of responder by BIRC Interval 4.2 to 22.6	0 % of responder by BIRC Interval 0.0 to 12.8	8.9 % of responder by BIRC Interval 3.0 to 19.6	0 % of responder by BIRC Interval 0.0 to 12.3

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set (FAS) - BYL719. All patients to whom alpelisib had been assigned by randomization.

A responder is defined by achieving a >=20% reduction from baseline in the sum of target lesion volumes (via BIRC) at Week 24, provided that none of the individual target lesions have a >=20% increase from baseline and in absence of progression of non-target lesions and without new lesions.

Outcome measures

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=54 Participants Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=56 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.
Proportion of Participants With a Response at Week 24 (by BIRC) in Groups 1 and 2	16.7 % of confirmed responder by BIRC Interval 7.0 to 31.1	19.6 % of confirmed responder by BIRC Interval 9.2 to 34.3	—	—

SECONDARY outcome

Timeframe: Up to Week 16

Population: Safety Set. All patients who received at least one dose of study treatment.

An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. This includes events reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative).

Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after the last dose of study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 30 days after the last study treatment.

Outcome measures

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=54 Participants Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=27 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=56 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm n=28 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 Adverse Events (AEs)	50 Participants	26 Participants	50 Participants	24 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 Treatment-related AEs	31 Participants	12 Participants	19 Participants	9 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 AEs with grade >=3	11 Participants	5 Participants	7 Participants	2 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 Treatment-related AEs with grade >=3	5 Participants	1 Participants	3 Participants	0 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 Serious Adverse Events (SAEs)	5 Participants	2 Participants	3 Participants	2 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 Treatment-related SAEs	3 Participants	0 Participants	1 Participants	0 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 AEs leading to discontinuation	1 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 Treatment-related AEs leading to discontinuation	1 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 AEs leading to dose adjustment/interruption	6 Participants	6 Participants	4 Participants	4 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 AEs leading to dose reduction	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 AEs leading to dose interruption	6 Participants	6 Participants	4 Participants	4 Participants
Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 AEs requiring additional therapy	37 Participants	19 Participants	43 Participants	15 Participants

SECONDARY outcome

Timeframe: Up to approximately 5 years

Type, frequency, seriousness, and severity of treatment-emergent adverse events per CTCAE v4.03 criteria in participants with PROS over time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

For adult and pediatric patients 12 years of age and older, the BPI item that assesses worst pain intensity in the past 24 hours was used. Patients respond to the item on an 11-point response scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Worst pain intensity was averaged weekly over a 7-day period if a patient had completed the questionnaire for at least 4 days in the 7-day period. The weekly mean was calculated based on the available assessments. Clinically important change at Week 16 was defined as a 2-point reduction for patients who had a pain intensity score ≥ 4 at baseline. For patients with a baseline score < 4, a 1-point reduction from baseline was also considered as a clinically important change.

Outcome measures

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=34 Participants Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=13 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=16 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm n=5 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.
Change From Baseline to Week 16 in Brief Pain Inventory (BPI) Worst Pain Intensity in Group 1 and 2 Change from BL at Week 4	-0.9 Score on a scale Standard Deviation 1.87	-0.2 Score on a scale Standard Deviation 1.54	0.2 Score on a scale Standard Deviation 0.73	0.3 Score on a scale Standard Deviation 0.82
Change From Baseline to Week 16 in Brief Pain Inventory (BPI) Worst Pain Intensity in Group 1 and 2 Change from BL at Week 8	-1.2 Score on a scale Standard Deviation 2.13	-0.7 Score on a scale Standard Deviation 1.43	-0.3 Score on a scale Standard Deviation 0.91	0.1 Score on a scale Standard Deviation 0.69
Change From Baseline to Week 16 in Brief Pain Inventory (BPI) Worst Pain Intensity in Group 1 and 2 Change from BL at Week 12	-0.9 Score on a scale Standard Deviation 2.55	-0.8 Score on a scale Standard Deviation 1.41	-0.4 Score on a scale Standard Deviation 1.01	0.4 Score on a scale Standard Deviation 0.62
Change From Baseline to Week 16 in Brief Pain Inventory (BPI) Worst Pain Intensity in Group 1 and 2 Change from BL at Week 16	-1.3 Score on a scale Standard Deviation 2.46	-0.1 Score on a scale Standard Deviation 1.49	-0.4 Score on a scale Standard Deviation 1.34	0.3 Score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 16

Population: Full Analysis Set (FAS). Only participants with an available value for the outcome measure.

A Patient Global Impression of Symptom Severity item was used to understand the overall severity of symptoms experienced and clinical meaningfulness of treatment effects experienced during this study. This item included 5 response options: no symptoms, mild, moderate, severe, and very severe.

Outcome measures

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=53 Participants Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=26 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Alpelisib Arm n=28 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm n=8 Participants Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 4 · Moderate	14 Participants	10 Participants	4 Participants	2 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 4 · Mild	20 Participants	5 Participants	6 Participants	3 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 8 · Severe	7 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 16 · Moderate	15 Participants	7 Participants	2 Participants	1 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 16 · Severe	6 Participants	5 Participants	0 Participants	0 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 4 · Severe	6 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 8 · Moderate	11 Participants	10 Participants	4 Participants	3 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 4 · No symptoms	12 Participants	9 Participants	15 Participants	3 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 4 · Very severe	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 8 · No symptoms	12 Participants	7 Participants	17 Participants	3 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 8 · Mild	20 Participants	6 Participants	6 Participants	2 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 8 · Very severe	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 16 · No symptoms	15 Participants	8 Participants	18 Participants	2 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 16 · Mild	14 Participants	6 Participants	6 Participants	4 Participants
Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 Week 16 · Very severe	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Percentage change from baseline in the sum of target lesion volume, MRI-measurable non-target lesion volume and all MRI measurable (target an non-target) lesion volume as assessed by BIRC.

Target lesions are defined as anatomically reproducibly defined tissue(s) masses, which may be composed of one or several tissue types, and can be accurately measured by imaging technique MRI. Target lesion(s) (up to 3) should be identified at screening, be at least 2 cm in the longest diameter at baseline (for each selected lesion) and may be further reproducibly assessed by MRI.

MRI-measurable non-target lesions are defined as all anatomic lesions other than selected as target and may be measured at radiologic assessment (at least 2 cm in the longest diameter at baseline, the volume may be further reproducibly assessed by MRI).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Percentage change from baseline in other non-target lesions (by BIRC). Non Target lesions are defined as:

• Anatomic lesions, limb/trunkal areas affected by PROS, organomegaly when they may be measured only by caliper/ruler (e.g., circumference of changed limb or body part)
• Truly non-measurable lesions (e.g., small lesions less than 2 cm on MRI, superficial visual lesions, masses, organomegaly, PROS-related enlargement of anatomic area identified by physical exam that is not measurable by reproducible imaging technique)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

The proportion of patients with new lesions (as assessed by BIRC) will be assessed throughout the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 17 Day 1 (Pre-dose, 1h post dose, 3h post dose, 5h post dose, 8h post dose , 24h post dose/ Pre-dose of Day 2), Week 20 Day 1 (Pre-dose, 3h post dose) and after Week 28, on Day 1 (Pre-dose and 3h post dose) 4 weeks after the first dose escalation

Maximum concentration of alpelisib following drug administration will be assessed for Group 1 and Group 2. After Week 28, blood samples will be collected only for participants who had dose escalation at next scheduled visit 4 weeks after the first dose escalation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 17 Day 1 (Pre-dose and 24 h post dose/ Pre-dose of Day 2), Week 20 Day 1 (Pre-dose) and after Week 28, on Day 1 (Pre-dose) 4 weeks after the first dose escalation

The trough observed concentration of alpelisib will be assessed for Group 1 and Group 2. After Week 28, blood samples will be collected only for participants who had dose escalation at next scheduled visit 4 weeks after the first dose escalation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Change in scores from Brief Pain Inventory (BPI) items, or Wong-Baker Faces Scale (age appropriate). The BPI item that assesses worst pain intensity in the past 24 hours will be used to assess pain intensity for adult participants (≥18 years old) and pediatric participants (≥12 years old). Participants respond to the item on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). For children under 12, the Wong-Baker Faces Scale will be used in place of the BPI worst pain intensity item. This scale is a single-item that includes drawings of 6 faces that are associated with both a numeric rating and a descriptor (ranging from 0/no hurt - 10/hurts worst)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Change in scores from the PROMIS-profile (Patient Reported Outcome Measurement Information System). The PROMIS Profiles are a group of PROMIS short forms measuring different domains of health-related quality of life (physical function, fatigue, ability to participate in social/peer relationships, pain interference, pain severity, anxiety, depression and sleep disturbance). All items include 5 response options, except for the pain intensity item, which has 11 response options.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Change in PGIS item. The PGIS is a single item to assess the participant's perception in the severity of their symptoms using a 5-point verbal rating scale, from "No symptoms" to "Very Severe".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first documented response until progression of PROS lesions or death, assessed up to approximately 5 years

Duration of response (DOR) is defined as the time from first documented response until progression of PROS lesions by BIRC or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Time from randomization/alpelisib treatment start date until the discontinuation of study treatment due to lack of efficacy (including unsatisfactory therapeutic effect, disease progression) or safety reasons (including adverse events, death).

Participants who complete the study or discontinue study treatment for other reasons (e.g. discontinuation due to Participant/Guardian decision, technical problems) will be censored at the date of last study treatment received.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16, 24, 40, 48, 72, 96 and thereafter every 48 weeks

Proportion of participants with overall clinical response reported as improvement, stable or worsening of clinical condition, as assessed by the investigator

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 40, 48, 72, 96, 144, 192, 240 and 264.

Response (yes/no) at scheduled protocol visit. Response is defined by achieving at least 20% reduction from baseline in the sum of target lesion volumes (1 to 3 lesions, assessed by MRI by a blinded independent review committee (BIRC)), provided that none of the individual target lesions has ≥ 20% increase from baseline and in absence of progression of non-target lesions and without new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 16

Change in PROS-related symptoms and complications/comorbidities associated with PROS up to Week 16 among participants with symptoms and complications/comorbidities present at baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to approximately 5 years

Change in PROS-related symptoms and complications/comorbidities among participants with symptoms and complications/comorbidities present at baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Proportion of participants with healthcare visit/hospitalized due to PROS will be assessed for Group 1 and Group 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to approximately 5 years

Proportion of participants requiring rescue surgery due to PROS will be assessed for Group 1 and Group 2.

Outcome measures

Outcome data not reported

Adverse Events

Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

Group 1 (Greater or Equal to 18 Years) - Placebo Arm

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Group 1 (Greater or Equal to 18 Years) Alpelisib Period/Alpelisib Arm

Serious events: 16 serious events

Other events: 52 other events

Deaths: 0 deaths

Group 1 (Greater or Equal to 18 Years) Alpelisib Period/Placebo Arm

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Group 1 (Greater or Equal to 18 Years) All Adults in Alpelisib Period

Serious events: 19 serious events

Other events: 78 other events

Deaths: 0 deaths

Group 2 (6-17 Years) - Alpelisib Arm

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Group 2 (6-17 Years) - Placebo Arm

Serious events: 2 serious events

Other events: 21 other events

Deaths: 1 deaths

Group 2 (6-17 Years) Alpelisib Period Alpelisib Arm

Serious events: 8 serious events

Other events: 53 other events

Deaths: 0 deaths

Group 2 (6-17 Years) Alpelisib Period Placebo Arm

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Group 2 (6-17 Years) All Pediatrics in Alpelisib Period

Serious events: 10 serious events

Other events: 76 other events

Deaths: 0 deaths

Group 4 (2-5 Years) All Pediatrics

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Group 5 (6-17 Years) All Pediatrics

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=54 participants at risk Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 1 (Greater or Equal to 18 Years) - Placebo Arm n=27 participants at risk Group 1: During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive placebo (125 mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Group 1 (Greater or Equal to 18 Years) Alpelisib Period/Alpelisib Arm n=54 participants at risk Group 1 (Greater or equal to 18 years) Alpelisib period/Alpelisib arm: Events for participants initially randomized to Alpelisib who continued to active treatment after week 16 until primary analysis cut-off date.	Group 1 (Greater or Equal to 18 Years) Alpelisib Period/Placebo Arm n=26 participants at risk Group 1 (Greater or equal to 18 years) Alpelisib period/Placebo arm: Events for participants initially randomized to Placebo who continued to active treatment after week 16 until primary analysis cut-off date.	Group 1 (Greater or Equal to 18 Years) All Adults in Alpelisib Period n=80 participants at risk Group 1 (Greater or equal to 18 years) All adults in Alpelisib Period: All events for adults participants in the Alpelisib Period.	Group 2 (6-17 Years) - Alpelisib Arm n=56 participants at risk Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm n=28 participants at risk Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Group 2 (6-17 Years) Alpelisib Period Alpelisib Arm n=56 participants at risk Group 2 (6-17 years) Alpelisib period Alpelisib arm: Events for participants initially randomized to Alpelisib who continued to active treatment after week 16 until primary analysis cut-off date.	Group 2 (6-17 Years) Alpelisib Period Placebo Arm n=26 participants at risk Group 2 (6-17 years) Alpelisib period Placebo arm: Events for participants initially randomized to Placebo who continued to active treatment after week 16 until primary analysis cut-off date.	Group 2 (6-17 Years) All Pediatrics in Alpelisib Period n=82 participants at risk Group 2 (6-17 years) All pediatrics in Alpelisib Period: All events for pediatrics participants aged 6-17 years old in the Alpelisib Period.	Group 4 (2-5 Years) All Pediatrics n=7 participants at risk Group 4 (2-5 years) All pediatrics: All events for pediatrics participants aged 2-5 years old	Group 5 (6-17 Years) All Pediatrics n=16 participants at risk Group 5 (6-17 years) All pediatrics: All events for pediatrics participants aged 6-17 years old.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Congenital, familial and genetic disorders Lymphatic malformation	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Ear and labyrinth disorders Vertigo positional	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Intussusception	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Pancreatitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Fatigue	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Inflammation	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Appendicitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Bronchitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations COVID-19	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Cellulitis	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Epstein-Barr virus infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Erysipelas	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Gastrointestinal viral infection	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Localised infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pharyngitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pneumonia	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	28.6% 2/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pyelonephritis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pyelonephritis acute	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Septic shock	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Staphylococcal infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Streptococcal infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Limb asymmetry	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Epilepsy	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Syncope	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Depression	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Suicidal ideation	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Suicide attempt	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Renal and urinary disorders Haematuria	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Renal and urinary disorders Prerenal failure	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Renal and urinary disorders Proteinuria	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Adnexal torsion	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Ovarian cyst	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Vascular disorders Embolism	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Vascular disorders Hypertension	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.

Other adverse events

Measure	Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm n=54 participants at risk Group 1 (Greater or equal to 18 years): During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive alpelisib (125 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 1 (Greater or Equal to 18 Years) - Placebo Arm n=27 participants at risk Group 1: During double-blind randomized study period (from baseline up to Week 16), adult participants will be randomized to receive placebo (125 mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Group 1 (Greater or Equal to 18 Years) Alpelisib Period/Alpelisib Arm n=54 participants at risk Group 1 (Greater or equal to 18 years) Alpelisib period/Alpelisib arm: Events for participants initially randomized to Alpelisib who continued to active treatment after week 16 until primary analysis cut-off date.	Group 1 (Greater or Equal to 18 Years) Alpelisib Period/Placebo Arm n=26 participants at risk Group 1 (Greater or equal to 18 years) Alpelisib period/Placebo arm: Events for participants initially randomized to Placebo who continued to active treatment after week 16 until primary analysis cut-off date.	Group 1 (Greater or Equal to 18 Years) All Adults in Alpelisib Period n=80 participants at risk Group 1 (Greater or equal to 18 years) All adults in Alpelisib Period: All events for adults participants in the Alpelisib Period.	Group 2 (6-17 Years) - Alpelisib Arm n=56 participants at risk Group 2: During double-blind randomized study period (from baseline up to Week 16, pediatric participants (6 to 17 years old) will be randomized to receive alpelisib (50 mg, oral, once daily). After Week 16, participants will continue their active treatment at the same dose level.	Group 2 (6-17 Years) - Placebo Arm n=28 participants at risk Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.	Group 2 (6-17 Years) Alpelisib Period Alpelisib Arm n=56 participants at risk Group 2 (6-17 years) Alpelisib period Alpelisib arm: Events for participants initially randomized to Alpelisib who continued to active treatment after week 16 until primary analysis cut-off date.	Group 2 (6-17 Years) Alpelisib Period Placebo Arm n=26 participants at risk Group 2 (6-17 years) Alpelisib period Placebo arm: Events for participants initially randomized to Placebo who continued to active treatment after week 16 until primary analysis cut-off date.	Group 2 (6-17 Years) All Pediatrics in Alpelisib Period n=82 participants at risk Group 2 (6-17 years) All pediatrics in Alpelisib Period: All events for pediatrics participants aged 6-17 years old in the Alpelisib Period.	Group 4 (2-5 Years) All Pediatrics n=7 participants at risk Group 4 (2-5 years) All pediatrics: All events for pediatrics participants aged 2-5 years old	Group 5 (6-17 Years) All Pediatrics n=16 participants at risk Group 5 (6-17 years) All pediatrics: All events for pediatrics participants aged 6-17 years old.
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Eye disorders Eyelid oedema	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	16.7% 9/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	24.1% 13/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	20.0% 16/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.9% 5/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 2/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	25.0% 14/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	26.9% 7/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	25.6% 21/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 3/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 4/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 7/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.0% 9/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Anal erythema	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Anal fissure	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Aphthous ulcer	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	13.0% 7/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	15.4% 4/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	13.8% 11/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Defaecation disorder	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	29.6% 16/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	18.5% 5/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	38.9% 21/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	30.8% 8/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	36.2% 29/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.9% 5/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 3/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	26.8% 15/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	23.1% 6/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	25.6% 21/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	28.6% 2/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	50.0% 8/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Dry mouth	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Faeces pale	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 4/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Gingival pain	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Lip swelling	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Mouth ulceration	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.0% 8/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Nausea	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.8% 4/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.8% 8/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.2% 9/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.9% 5/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 2/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 8/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	13.4% 11/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Oral pain	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Stomatitis	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Toothache	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 6/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.8% 8/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.5% 6/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 6/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 2/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	17.9% 10/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	26.9% 7/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	20.7% 17/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	57.1% 4/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	31.2% 5/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Asthenia	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.5% 6/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Chest pain	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 3/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Fatigue	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.8% 4/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	19.2% 5/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.0% 8/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.9% 5/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 3/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 8/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.0% 9/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Gait disturbance	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Haemorrhagic cyst	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Induration	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Inflammation	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.8% 7/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.3% 6/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Influenza like illness	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.1% 5/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Malaise	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 4/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Peripheral swelling	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Pyrexia	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.8% 8/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 10/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.9% 5/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	30.4% 17/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	30.8% 8/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	30.5% 25/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	57.1% 4/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	31.2% 5/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Immune system disorders Drug hypersensitivity	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Adenovirus infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Bronchitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations COVID-19	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.8% 4/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	31.5% 17/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	25.0% 20/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	16.1% 9/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 3/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	23.2% 13/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	18.3% 15/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Conjunctivitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Conjunctivitis bacterial	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Cystitis	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Dientamoeba infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Ear infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Fungal foot infection	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Gastroenteritis	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	13.0% 7/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.0% 8/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.1% 5/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Gastroenteritis viral	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Impetigo	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Influenza	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 3/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.5% 6/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 2/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 7/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.2% 10/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Lymphangitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Nasopharyngitis	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	22.2% 12/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	16.2% 13/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 4/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	16.1% 9/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	26.9% 7/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	19.5% 16/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Oral herpes	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Otitis media	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Paronychia	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pharyngitis	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 4/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Respiratory tract infection	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Respiratory tract infection viral	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Rhinitis	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 4/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Sapovirus infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Scarlet fever	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Sinusitis	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Tonsillitis	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Tooth abscess	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.9% 5/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 8/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.2% 10/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 2/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.8% 7/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Varicella	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Viral infection	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Viral pharyngitis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Viral rash	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 4/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Joint injury	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Limb injury	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Scar	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Blood bilirubin increased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Blood creatine phosphokinase increased	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.5% 6/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Blood creatinine increased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Blood phosphorus decreased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Fibrin D dimer increased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.1% 5/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Haemoglobin decreased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Lipase increased	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 2/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.8% 7/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Lymph node palpable	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Neutrophil count increased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Pancreatic enzymes increased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Weight decreased	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.0% 8/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Weight increased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations White blood cell count decreased	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Decreased appetite	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	15.4% 4/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 10/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 6/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.5% 7/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	28.6% 2/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 2/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	15.4% 4/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.2% 9/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.5% 6/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.3% 6/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	13.0% 7/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 10/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Growth retardation	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 4/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Dizziness	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 4/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	18.5% 10/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	16.2% 13/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	23.2% 13/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	15.4% 4/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	20.7% 17/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in jaw	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Headache	18.5% 10/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.8% 4/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	29.6% 16/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	23.1% 6/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	27.5% 22/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	19.6% 11/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 3/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	35.7% 20/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	19.2% 5/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	30.5% 25/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	28.6% 2/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Migraine	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Anxiety	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 2/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 2/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Encopresis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Insomnia	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 3/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Irritability	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Mental disorder	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Amenorrhoea	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Intermenstrual bleeding	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Menstruation irregular	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 3/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 2/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.8% 8/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.0% 8/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 4/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 1/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 7/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.0% 9/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.1% 2/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 5/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 6/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	16.1% 9/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	13.4% 11/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Acne	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.6% 3/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 3/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Alopecia	20.4% 11/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	38.9% 21/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	15.4% 4/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	31.2% 25/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 6/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.8% 8/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	18.8% 3/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Dry skin	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 2/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	23.1% 6/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	15.0% 12/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 2/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.8% 7/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.4% 3/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.7% 2/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.1% 5/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Ingrowing nail	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 2/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 2/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	15.4% 4/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.5% 6/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 3/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	9.3% 5/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.7% 1/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 6/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.5% 3/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.2% 9/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 2/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.7% 6/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.3% 6/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.8% 1/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 1/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Vascular disorders Haematoma	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.3% 1/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Vascular disorders Haemorrhage	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	7.4% 2/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 1/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 1/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Vascular disorders Peripheral vascular disorder	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/27 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/54 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/80 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/28 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/56 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/26 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/82 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/7 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the interim analysis (20-Mar-2024), approximately 35 months. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

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

Restriction type: OTHER