Trial Outcomes & Findings for Phase III Cat-PAD Study (NCT NCT01620762)

NCT ID: NCT01620762

Last Updated: 2018-06-15

Results Overview

The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3. RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1408 participants
• Primary outcome timeframe: 52-54 weeks after randomisation
• Results posted on: 2018-06-15

Participant Flow

Participant milestones

Measure	Cat-PAD Treatment 1 (1 Course) Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo Placebo: 1 dose every 4 weeks
Overall Study STARTED	468	470	470
Overall Study COMPLETED	420	412	417
Overall Study NOT COMPLETED	48	58	53

Reasons for withdrawal

Measure	Cat-PAD Treatment 1 (1 Course) Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo Placebo Placebo: 1 dose every 4 weeks
Overall Study Protocol Violation	1	1	1
Overall Study Adverse Event	9	5	2
Overall Study Withdrawal by Subject	23	26	27
Overall Study Lost to Follow-up	11	17	10
Overall Study Protocol deviation	1	1	6
Overall Study Subject deterioration	0	1	1
Overall Study Non-specified	3	6	5
Overall Study Use of prohibted therapies	0	1	1

Baseline Characteristics

Phase III Cat-PAD Study

Baseline characteristics by cohort

Measure	Cat-PAD Treatment 1 (1 Course) n=468 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=470 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=470 Participants Placebo Placebo: 1 dose every 4 weeks	Total n=1408 Participants Total of all reporting groups
Age, Categorical <=18 years	29 Participants n=5 Participants	29 Participants n=7 Participants	32 Participants n=5 Participants	90 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	439 Participants n=5 Participants	441 Participants n=7 Participants	438 Participants n=5 Participants	1318 Participants n=4 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
Sex: Female, Male Female	301 Participants n=5 Participants	317 Participants n=7 Participants	317 Participants n=5 Participants	935 Participants n=4 Participants
Sex: Female, Male Male	167 Participants n=5 Participants	153 Participants n=7 Participants	153 Participants n=5 Participants	473 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	458 Participants n=5 Participants	468 Participants n=7 Participants	463 Participants n=5 Participants	1389 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants

PRIMARY outcome

Timeframe: 52-54 weeks after randomisation

Population: Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome.

CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3.

RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6.

Outcome measures

Measure	Cat-PAD Treatment 1 (1 Course) n=417 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=414 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=414 Participants Placebo Placebo: 1 dose every 4 weeks
Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo	1.04 units on a scale Standard Error 0.068	1.00 units on a scale Standard Error 0.068	1.05 units on a scale Standard Error 0.068

SECONDARY outcome

Timeframe: 52-54 weeks after randomisation

Population: Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo.

Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation.

Outcome measures

Measure	Cat-PAD Treatment 1 (1 Course) n=417 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=414 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=414 Participants Placebo Placebo: 1 dose every 4 weeks
Mean TRSS	5.67 units on a scale Standard Error 0.358	5.54 units on a scale Standard Error 0.356	5.87 units on a scale Standard Error 0.357

SECONDARY outcome

Timeframe: 52-54 weeks after randomisation

Population: Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.

Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation.

Outcome measures

Measure	Cat-PAD Treatment 1 (1 Course) n=417 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=414 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=414 Participants Placebo Placebo: 1 dose every 4 weeks
Mean Daily TNSS in Cat-PAD Compared With Placebo	3.48 units on a scale Standard Error 0.197	3.36 units on a scale Standard Error 0.196	3.44 units on a scale Standard Error 0.196

SECONDARY outcome

Timeframe: 52-54 weeks after randomisation

Population: Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups

TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms.

Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation.

Outcome measures

Measure	Cat-PAD Treatment 1 (1 Course) n=417 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=414 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=414 Participants Placebo Placebo: 1 dose every 4 weeks
Mean Daily TOSS in Cat-PAD Compared to Placebo	2.20 units on a scale Standard Error 0.179	2.19 units on a scale Standard Error 0.178	2.42 units on a scale Standard Error 0.179

SECONDARY outcome

Timeframe: 52-54 weeks after randomisation

Population: Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

Mean RMS (Rescue medication score) in Cat-PAD treatment groups compared with placebo groups.

The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 52-54 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive.

Outcome measures

Measure	Cat-PAD Treatment 1 (1 Course) n=417 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=414 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=414 Participants Placebo Placebo: 1 dose every 4 weeks
Mean RMS in Cat-PAD Compared With Placebo	0.34 units on a scale Standard Error 0.038	0.31 units on a scale Standard Error 0.037	0.32 units on a scale Standard Error 0.037

SECONDARY outcome

Timeframe: 52-54 weeks after randomisation

Population: Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (52-54 weeks after randomisation).

The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six.

Outcome measures

Measure	Cat-PAD Treatment 1 (1 Course) n=396 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=403 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=393 Participants Placebo Placebo: 1 dose every 4 weeks
Mean RQLQ Score in Cat-PAD Compared With Placebo	1.26 units on a scale Standard Error 0.080	1.26 units on a scale Standard Error 0.079	1.25 units on a scale Standard Error 0.079

SECONDARY outcome

Timeframe: 52-54 week after randomisaiton

Population: Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.

The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 52-54 weeks after randomisation.

Outcome measures

Measure	Cat-PAD Treatment 1 (1 Course) n=417 Participants Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=414 Participants Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=414 Participants Placebo Placebo: 1 dose every 4 weeks
Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use	9.44 days Standard Error 0.56	10.11 days Standard Error 0.556	9.76 days Standard Error 0.557

Adverse Events

Cat-PAD Treatment 1 (1 Course)

Serious events: 11 serious events

Other events: 298 other events

Deaths: 0 deaths

Cat-PAD Treatment 2 (2 Courses)

Serious events: 13 serious events

Other events: 299 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 305 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cat-PAD Treatment 1 (1 Course) n=467 participants at risk Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=470 participants at risk Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=470 participants at risk Placebo Placebo: 1 dose every 4 weeks
Vascular disorders Deep Vein Thrombosis	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Immune system disorders Hypersensitivity	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Psychiatric disorders Major depression	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Psychiatric disorders Suicidal ideation	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Injury, poisoning and procedural complications Skull fracture	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Injury, poisoning and procedural complications Procedural pain	0.43% 2/467 • Number of events 2 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Injury, poisoning and procedural complications Comminuted fracture	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Cardiac disorders Myocardial infarction	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Asthma	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Nervous system disorders Vascular headache	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Gastrointestinal disorders Vomiting	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Renal and urinary disorders Hydonephrosis	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Renal and urinary disorders IgA nephropathy	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Musculoskeletal and connective tissue disorders Femoroacetabular impingement	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Endocrine disorders Hypthyroidism	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Acarodermatitis	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Pyelonephritis	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Appendicitis	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Diverticulitis	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Scrotal abscess	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Infectious mononucleosis	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Upper respiratory tract infection	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Cellulitis	0.00% 0/467 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.21% 1/470 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.00% 0/470 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.

Other adverse events

Measure	Cat-PAD Treatment 1 (1 Course) n=467 participants at risk Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks	Cat-PAD Treatment 2 (2 Courses) n=470 participants at risk Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks	Placebo n=470 participants at risk Placebo Placebo: 1 dose every 4 weeks
Immune system disorders Allergy to animal	1.9% 9/467 • Number of events 9 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.9% 9/470 • Number of events 11 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.3% 11/470 • Number of events 13 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Cough	3.9% 18/467 • Number of events 26 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.8% 18/470 • Number of events 27 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	5.1% 24/470 • Number of events 26 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Orophayngeal pai	3.4% 16/467 • Number of events 20 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.4% 16/470 • Number of events 20 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.4% 16/470 • Number of events 18 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Athma	3.6% 17/467 • Number of events 21 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.0% 14/470 • Number of events 15 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.4% 16/470 • Number of events 17 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.6% 12/467 • Number of events 19 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.5% 7/470 • Number of events 13 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.3% 11/470 • Number of events 12 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Nervous system disorders Headache	5.4% 25/467 • Number of events 78 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	8.3% 39/470 • Number of events 86 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	7.4% 35/470 • Number of events 76 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
General disorders Injection site pruritus	4.1% 19/467 • Number of events 51 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.8% 13/470 • Number of events 45 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.3% 11/470 • Number of events 41 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
General disorders Injection site urticaria	3.6% 17/467 • Number of events 95 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.9% 9/470 • Number of events 43 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.5% 7/470 • Number of events 41 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
General disorders Pyrexia	1.3% 6/467 • Number of events 6 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.6% 12/470 • Number of events 13 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.3% 6/470 • Number of events 7 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Gastrointestinal disorders Nausea	1.9% 9/467 • Number of events 10 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.6% 12/470 • Number of events 12 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.64% 3/470 • Number of events 3 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Gastrointestinal disorders Diarrhoea	1.1% 5/467 • Number of events 6 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.3% 6/470 • Number of events 7 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.6% 12/470 • Number of events 15 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Gastrointestinal disorders Toothache	0.21% 1/467 • Number of events 1 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.3% 11/470 • Number of events 12 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.1% 5/470 • Number of events 5 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Musculoskeletal and connective tissue disorders Back pain	2.6% 12/467 • Number of events 20 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.9% 9/470 • Number of events 12 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.2% 15/470 • Number of events 20 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Musculoskeletal and connective tissue disorders Athralgia	1.5% 7/467 • Number of events 8 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.6% 12/470 • Number of events 16 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.4% 16/470 • Number of events 16 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Nasopharyngitis	18.2% 85/467 • Number of events 124 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	18.5% 87/470 • Number of events 128 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	19.1% 90/470 • Number of events 127 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Upper respiratory tract infection	7.9% 37/467 • Number of events 48 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	7.2% 34/470 • Number of events 41 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	8.9% 42/470 • Number of events 60 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Sinusitis	4.5% 21/467 • Number of events 26 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	5.1% 24/470 • Number of events 29 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	4.9% 23/470 • Number of events 24 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Bronchitis	4.9% 23/467 • Number of events 27 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	4.9% 23/470 • Number of events 25 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	4.0% 19/470 • Number of events 21 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Pharyngitis	2.4% 11/467 • Number of events 11 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.8% 18/470 • Number of events 20 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	3.0% 14/470 • Number of events 17 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Influenza	1.9% 9/467 • Number of events 9 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.1% 5/470 • Number of events 5 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	4.0% 19/470 • Number of events 20 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Urinary tract infection	1.9% 9/467 • Number of events 11 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.6% 12/470 • Number of events 16 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.3% 11/470 • Number of events 13 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Tonsillitis	1.9% 9/467 • Number of events 11 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.1% 10/470 • Number of events 12 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	1.5% 7/470 • Number of events 7 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
Infections and infestations Rhinitis	1.7% 8/467 • Number of events 8 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	0.85% 4/470 • Number of events 5 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.	2.1% 10/470 • Number of events 13 • Up to 52 weeks after randomisation The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.

Additional Information

VP Clinical Operations

Circassia Ltd

Phone: +44 1865 405560

Results disclosure agreements

• Principal investigator is a sponsor employee To avoid disclosures that may affect the proprietary rights of the Sponsor, the Investigator agrees to allow Circassia the opportunity to review all manuscripts and abstracts 60 days prior to submission for publication. Circassia reserves the right to include the report of this study in any regulatory documentation or submission or in any informational materials.
• Publication restrictions are in place

Restriction type: OTHER