Trial Outcomes & Findings for A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment (NCT NCT00537407)

NCT ID: NCT00537407

Last Updated: 2016-02-17

Results Overview

Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline to Day 29
• Results posted on: 2016-02-17

Participant Flow

Participant milestones

Measure	Treatment Arm A Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm B Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm C Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Part 1 Weeks 1-4 STARTED	10	9	11	10	10
Part 1 Weeks 1-4 COMPLETED	10	9	11	10	10
Part 1 Weeks 1-4 NOT COMPLETED	0	0	0	0	0
Part 2 Weeks 5-48 or 72 STARTED	10	9	11	10	10
Part 2 Weeks 5-48 or 72 COMPLETED	2	1	2	4	3
Part 2 Weeks 5-48 or 72 NOT COMPLETED	8	8	9	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment

Baseline characteristics by cohort

Measure	Treatment Arm A n=10 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm B n=9 Participants Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm C n=11 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	50 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	51.4 years STANDARD_DEVIATION 6.62 • n=5 Participants	52.6 years STANDARD_DEVIATION 5.94 • n=7 Participants	49.9 years STANDARD_DEVIATION 10.71 • n=5 Participants	48.5 years STANDARD_DEVIATION 9.87 • n=4 Participants	52.8 years STANDARD_DEVIATION 6.51 • n=21 Participants	51.0 years STANDARD_DEVIATION 8.09 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	21 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	29 Participants n=8 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants	10 participants n=4 Participants	10 participants n=21 Participants	50 participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline to Day 29

Population: Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.

Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.

Outcome measures

Measure	Treatment Arm A n=10 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)	-0.881 Log10(IU/mL) Standard Deviation 1.0099	-2.321 Log10(IU/mL) Standard Deviation 1.4644	-2.020 Log10(IU/mL) Standard Deviation 1.4031	—	—

SECONDARY outcome

Timeframe: Baseline to Day 29

Population: Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.

Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.

Outcome measures

Measure	Treatment Arm A n=9 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=11 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)	0.285 Log10(IU/mL) Standard Deviation 0.3273	-0.608 Log10(IU/mL) Standard Deviation 0.7558	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.

Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.

Outcome measures

Measure	Treatment Arm A n=10 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=9 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=11 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
log10 Hepatitis C Virus RNA at Day 29	5.567 Log10(IU/mL) Standard Deviation 1.0165	6.662 Log10(IU/mL) Standard Deviation 0.3295	5.827 Log10(IU/mL) Standard Deviation 0.7270	4.000 Log10(IU/mL) Standard Deviation 1.4325	4.245 Log10(IU/mL) Standard Deviation 1.6337

SECONDARY outcome

Timeframe: Day 29

Population: Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.

A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL).

Outcome measures

Measure	Treatment Arm A n=10 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=9 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=11 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Percentage of Participants With a Rapid Viral Response at Day 29	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 33.6	0.0 percentage of participants Interval 0.0 to 28.5	10 percentage of participants Interval 0.3 to 44.5	10 percentage of participants Interval 0.3 to 44.5

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.

A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline.

Outcome measures

Measure	Treatment Arm A n=10 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=9 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=11 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Percentage of Participants With an Early Viral Response at Week 12	30.0 percentage of participants	11.1 percentage of participants	27.3 percentage of participants	70.0 percentage of participants	30.0 percentage of participants

SECONDARY outcome

Timeframe: End of treatment (Week 48 or 72)

Population: Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.

A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL).

Outcome measures

Measure	Treatment Arm A n=10 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=9 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=11 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)	20.0 percentage of participants	11.1 percentage of participants	18.2 percentage of participants	10.0 percentage of participants	30.0 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks after the end of treatment (Week 72 or 96)

Population: Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.

A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL).

Outcome measures

Measure	Treatment Arm A n=10 Participants Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=9 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=11 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 Participants Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 Participants Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)	0.0 percentage of participants	0.0 percentage of participants	9.1 percentage of participants	0.0 percentage of participants	10.0 percentage of participants

Adverse Events

Treatment Arm A

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Treatment Arm B

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Treatment Arm C

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Treatment Arm D

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Treatment Arm E

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm A n=10 participants at risk Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm B n=9 participants at risk Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm C n=11 participants at risk Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 participants at risk Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 participants at risk Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Infections and infestations Acute Pyelonephritis	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.

Other adverse events

Measure	Treatment Arm A n=10 participants at risk Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm B n=9 participants at risk Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm C n=11 participants at risk Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm D n=10 participants at risk Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets	Treatment Arm E n=10 participants at risk Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets
Blood and lymphatic system disorders Anaemia	40.0% 4/10 • Number of events 5 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Blood and lymphatic system disorders Neutropenia	50.0% 5/10 • Number of events 5 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	36.4% 4/11 • Number of events 4 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	40.0% 4/10 • Number of events 6 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Endocrine disorders Hypothyroidism	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Eye disorders Diplopia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Eye disorders Dry Eye	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Eye disorders Foreign body sensation in eyes	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Eye disorders Photophobia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Eye disorders Vision Blurred	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Abdominal Distension	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Abdominal Pain	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	22.2% 2/9 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Aphthous Stomatitis	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Chapped lips	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Constipation	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Faecal Volume Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Faeces Pale	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Flatulence	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Gingival pain	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Gingivitis	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Hunger	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Nausea	30.0% 3/10 • Number of events 4 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	18.2% 2/11 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	30.0% 3/10 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	30.0% 3/10 • Number of events 5 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Salivary Hypersecretion	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Sensitivity of Teeth	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Stomatitis	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Tooth disorder	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Asthenia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Chest Discomfort	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Chills	30.0% 3/10 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Early Satiety	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Face oedema	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Fatigue	40.0% 4/10 • Number of events 5 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	22.2% 2/9 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	36.4% 4/11 • Number of events 4 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	50.0% 5/10 • Number of events 5 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	80.0% 8/10 • Number of events 10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Influenza Like Illness	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Injection Site Erythema	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Injection Site Haematoma	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Injection Site Reaction	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Irritability	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	27.3% 3/11 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Local swelling	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Malaise	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Pain	30.0% 3/10 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Pyrexia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	30.0% 3/10 • Number of events 5 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
General disorders Thirst	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Hepatobiliary disorders Jaundice	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Dermatitis infected	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Nail bed infection	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Nasopharyngitis	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Oral Herpes	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Pharyngitis streptococcal	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Pilonidal cyst	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Pyelonephritis acute	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Tonsillitis	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Tooth abscess	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Infections and infestations Urinary tract infection	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Alanine Aminotransferase Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Aspartate Aminotransferase Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Bacteria urine	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Blood Bilirubin Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Blood Lactate Dehydrogenase Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Blood Thyroid Stimulating Hormone Increased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Blood Triglycerides Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Blood glucose increased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Blood phosphorus decreased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Blood pressure increased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Gamma-glutamyltransferase Increased	10.0% 1/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	18.2% 2/11 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Haematocrit decreased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Haemoglobin decreased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Lymphocyte count decreased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Mean cell volume increased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Neutrophil Count Decreased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Neutrophil count increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Osteocalcin Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Platelet Count Decreased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Red blood cells urine	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Urine Output Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations Weight decreased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations White blood cell count decreased	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Investigations White blood cell count increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Metabolism and nutrition disorders Decreased Appetite	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Metabolism and nutrition disorders Gout	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	27.3% 3/11 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	36.4% 4/11 • Number of events 4 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Musculoskeletal and connective tissue disorders Osteopenia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Musculoskeletal and connective tissue disorders Resorption Bone Increased	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Nervous system disorders Dizziness	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	18.2% 2/11 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Nervous system disorders Headache	30.0% 3/10 • Number of events 4 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	22.2% 2/9 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	18.2% 2/11 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	60.0% 6/10 • Number of events 8 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	30.0% 3/10 • Number of events 4 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Nervous system disorders Hypoaesthesia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Nervous system disorders Mental Impairment	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Nervous system disorders Parosmia	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Nervous system disorders Psychomotor Hyperactivity	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Psychiatric disorders Agitation	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Psychiatric disorders Anxiety	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	27.3% 3/11 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Psychiatric disorders Depressed Mood	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Psychiatric disorders Depression	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Psychiatric disorders Insomnia	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	22.2% 2/9 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	36.4% 4/11 • Number of events 4 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	50.0% 5/10 • Number of events 5 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Psychiatric disorders Memory impairment	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Renal and urinary disorders Chromaturia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Renal and urinary disorders Glycosurea	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Renal and urinary disorders Haematuria	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Renal and urinary disorders Pollakiuria	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Renal and urinary disorders Proteinuria	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Reproductive system and breast disorders Menstruation Irregular	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Dyspneoa	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Rales	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	22.2% 2/9 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 3 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Pruritus Generalised	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Rash	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	22.2% 2/9 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Rash Macular	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Rash Maculo-papular	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	9.1% 1/11 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Skin Odour Abnormal	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Skin and subcutaneous tissue disorders Skin lesion	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Vascular disorders Hot Flush	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	11.1% 1/9 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Vascular disorders Hypertension	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	20.0% 2/10 • Number of events 2 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
Vascular disorders Venous insufficiency	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/9 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/11 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	0.00% 0/10 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.	10.0% 1/10 • Number of events 1 • Within 72 weeks Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.

Additional Information

Jean-Maurice Dumont, Vice President Medical Affairs

Debiopharm International S.A.

Phone: 4121 321 01 11

Email: jean-maurice.dumont@debiopharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER