Trial Outcomes & Findings for Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency (NCT NCT03113760)

NCT ID: NCT03113760

Last Updated: 2025-07-02

Results Overview

The primary outcome measure is the time to first occurrence of disease reactivation during the 16-week RW phase. Method of assessment: Biomarkers (CRP / Ferritin) and clinical manifestations of systemic inflammation and end-organ damage.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 15 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	Single Arm Open-Label - Tadekinig Alfa The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.	Randomized Double-Blind Placebo-Controlled - Placebo Arm The Randomized Double-Blind Placebo-Controlled (RDBPC) Analysis Set includes 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase. As defined in the study protocol and statistical analysis plan, this patient is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Initial 18 Weeks Treatment Phase STARTED	14	1	0	0
Initial 18 Weeks Treatment Phase COMPLETED	10	0	0	0
Initial 18 Weeks Treatment Phase NOT COMPLETED	4	1	0	0
Randomized Withdrawal Phase STARTED	0	0	5	5
Randomized Withdrawal Phase COMPLETED	0	0	5	5
Randomized Withdrawal Phase NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Measure	Single Arm Open-Label - Tadekinig Alfa The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.	Randomized Double-Blind Placebo-Controlled - Placebo Arm The Randomized Double-Blind Placebo-Controlled (RDBPC) Analysis Set includes 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase. As defined in the study protocol and statistical analysis plan, this patient is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Initial 18 Weeks Treatment Phase Withdrawal by Subject	2	0	0	0
Initial 18 Weeks Treatment Phase Adverse Event	1	0	0	0
Initial 18 Weeks Treatment Phase Disease relapse	1	1	0	0

Baseline Characteristics

Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency

Baseline characteristics by cohort

Measure	Single Arm Open-Label - Tadekinig Alfa n=14 Participants The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.	Randomized Double-Blind Placebo-Controlled - Placebo Arm n=1 Participants The Randomized Double-Blind Placebo-Controlled Analysis Set (RDBPC-AS) includes 1 patient treated with Placebo in the first treatment phase.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Germany	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

The primary outcome measure is the time to first occurrence of disease reactivation during the 16-week RW phase.

Method of assessment: Biomarkers (CRP / Ferritin) and clinical manifestations of systemic inflammation and end-organ damage.

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=5 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 Participants The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Prevention of Flares	2.71 Weeks Interval 1.86 to Median time to first occurrence of DR was 2.71 weeks for the placebo group and not applicable in the Tadekinig alfa group due to the small number of patients with a disease reactivation.	NA Weeks Median time to first occurrence of DR was 2.71 weeks for the placebo group and not applicable in the Tadekinig alfa group due to the small number of patients with a disease reactivation.	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Best response to therapy during the SAOL phase including either complete response, partial response or disease improvement.

Method of assessment: Biomarkers (CRP / Ferritin) and clinical manifestations of systemic inflammation and end-organ damage.

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Best Response Complete response	1 Participants	—	—
Best Response Partial response	10 Participants	—	—
Best Response Disease improvement	3 Participants	—	—
Best Response No response	0 Participants	—	—

SECONDARY outcome

Timeframe: The actual mean treatment duration in the SAOL phase was 17.6 weeks (minimum / maximum 5.9 / 22.1 weeks).

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Duration of response to therapy during the SAOL phase is assessed for patients having achieved a complete or partial response to therapy during the SAOL phase. It is defined as the time from first evaluation of partial or complete response until the time of subsequent disease reactivation or end of SAOL phase, whichever occurs first.

Of the 11 patients achieving partial or complete response during the SAOL phase, 8 maintained treatment response until the end of the SAOL phase.

2 of the 11 patients had a temporary disease reactivation during the protocol mandated steroid weaning in the SAOL phase; 1 of the 11 patients was withdrawn from blinded treatment following a disease reactivation.

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=11 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Duration of Response During the SAOL Phase (Until End of Phase or Disease Reactivation)	11.9 Weeks Interval 6.4 to 17.0	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: Change from Baseline to Week 18 in mAIDAI Total Score. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

The mAIDAI (modified autoinflammatory disease activitiy index) is an assessment of global disease activity that measures 14 different components for disease as either absent (0 points) or present (2 points for Uveitis 3+/4+ and 1 point for all other symptoms) at each visit. The mAIDAI total score is the sum of the points assigned across all components and ranges from 0 to 15, with a higher score indicating more severe disease activity.

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Change From Baseline in mAIDAI Total Score in the SAOL Phase	-3.9 score Standard Deviation 0.74	—	—

SECONDARY outcome

Timeframe: 34 weeks

Population: Values indicate change from Baseline to End of Phase results. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Laboratory measure

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 Participants The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm n=5 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Change From Baseline in Serum Ferritin	-8558.7 ng/mL Standard Deviation 15700.51	-109.5 ng/mL Standard Deviation 167.4	211.8 ng/mL Standard Deviation 359.1

SECONDARY outcome

Timeframe: 34 weeks

Population: Values indicate change from Baseline to End of Phase results. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Laboratory measure

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 Participants The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm n=5 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Change From Baseline in Serum CRP	-2.28 ug/mL Standard Deviation 4.28	-0.02 ug/mL Standard Deviation 0.19	0.24 ug/mL Standard Deviation 1.35

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Clinical assessments if present at Baseline; number displays percentage of patients with resolution of individual disease component at Week 18 or early termination visit based on the number of patients with a baseline assessment for the component of interest.

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Resolution of Fevers, Hepato/Splenomegaly and Skin Rash Resolution of Organomegaly	54 Percentage of patients with resolution	—	—
Resolution of Fevers, Hepato/Splenomegaly and Skin Rash Resolution of Skin rash	75 Percentage of patients with resolution	—	—
Resolution of Fevers, Hepato/Splenomegaly and Skin Rash Resolution of Fever	100 Percentage of patients with resolution	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - AST (SGOT)	-286.2 U/L Standard Deviation 727.5	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - ALT (SGPT)	-581.2 U/L Standard Deviation 1324.21	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - Albumin	4.7 g/L Standard Deviation 5.66	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - Hemoglobin	17.2 g/L Standard Deviation 18.24	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - Platelets	24.0 cells x 10^9/L Standard Deviation 143.10	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - Erythrocyte Sedimentation Rate	-6.3 mm/h Standard Deviation 10.47	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - Fibrinogen	12.7 mg/dL Standard Deviation 108.10	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Change from Baseline mean value to Week 18 mean value

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Improvement in Laboratory Markers - D-Dimer	-3.85 mg/L Standard Deviation 5.89	—	—

SECONDARY outcome

Timeframe: 34 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Length of hospitalisation; emergency room attendance and unscheduled visits for treatment of disease reactivations not included

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 Participants The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm n=5 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Hospital Length of Stay Baseline hospitalization	54 days Interval 20.0 to 63.5	NA days No patient hospitalized at start of RW-phase	NA days No patient hospitalized at start of RW-phase
Hospital Length of Stay Subsequent hospitalization	5.5 days Interval 4.0 to 32.0	0 days Interval 0.0 to 0.0	0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 34 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

The PGA is a direct surrogate of how a patient functions and assesses the severity of disease-related (auto-inflammatory) symptoms by selecting an integer score from 0 (no impact on subject; no symptoms) to 10 (no normal activities possible; highest severity of symptoms possible).

The outcome lists the change from baseline of treatment phase to end of treatment phase/study in the PGA symptom severity score.

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 Participants The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm n=5 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Change in Physician Global Assessment (PGA)	-5.8 score Standard Deviation 2.1	0.4 score Standard Deviation 0.89	2.0 score Standard Deviation 3.39

SECONDARY outcome

Timeframe: 16 weeks

The individual disease-related symptoms score is the sum of (x) individual symptom scores within domain each ranging from 0 (None) to 5 (Very severe) for: general wellbeing (5), gastrointestinal (7), musculoskeletal (5), skin (2), eye (2), central nervous system (3), and lymphatic (2). Highest values indicate more severe disease-related symptoms within total score range from 0-130.

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=3 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=2 Participants The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Change in Patient/Caregiver Qualitative Evaluation of Health Status in Randomized Withdrawal Phase Change from start to end of RW phase	-3.7 score Standard Deviation 5.7	44.0 score Standard Deviation 17.0	—
Change in Patient/Caregiver Qualitative Evaluation of Health Status in Randomized Withdrawal Phase Start of RW phase	11.3 score Standard Deviation 8.6	2.0 score Standard Deviation 2.8	—
Change in Patient/Caregiver Qualitative Evaluation of Health Status in Randomized Withdrawal Phase End of RW phase	7.7 score Standard Deviation 7.1	46.0 score Standard Deviation 14.1	—

SECONDARY outcome

Timeframe: 34 weeks (SAOL + RW phases)

Generation of anti-recombinant human IL-18BP (anti-rhIL-18BP) antibodies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 34 weeks (SAOL + RW phases)

Population: Patients reporting at least one AESI. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Adverse events of special interest (AESIs) are defined for this protocol as injection site reactions (including pruritus, erythema, swelling).

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 Participants The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm n=5 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Local Tolerability at the Injection Site (as Defined by Number of Participants With Adverse Events of Special Interest)	8 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Disease reactivation rate for individual subjects (number of disease reactivations experienced per week while each subject is on the study treatment during the SAOL phase)

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Disease Reactivation Rate	0.0 Disease reactivation rate per week Standard Deviation 0.09	—	—

SECONDARY outcome

Timeframe: 18 weeks

Population: Treatment failures were defined as patients who experienced at least 1 disease reactivation. Disease reactivation includes full or partial disease reactivation after the first assessment indicating partial or complete response during the SAOL phase as defined in the statistical analysis plan. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan.

Treatment failures (i.e. patients who experience at least one disease reactivation) during the SAOL phase

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Treatment Failures	3 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 weeks

Population: The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.

Response to therapy (including complete response and partial response) in the SAOL phase from Week 10 onwards and observed at least at 2 consecutive visits at least 2 weeks apart during the SAOL phase

Outcome measures

Measure	Randomized Withdrawal - Placebo Arm n=14 Participants The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.
Response to Therapy - Key Secondary Efficacy Endpoint	10 Participants	—	—

Adverse Events

Single Arm Open-Label - Tadekinig Alfa

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Randomized Double-Blind Placebo-Controlled - Placebo Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Randomized Withdrawal - Tadekinig Alfa Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Randomized Withdrawal - Placebo Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Screening Phase

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Arm Open-Label - Tadekinig Alfa n=14 participants at risk The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.	Randomized Double-Blind Placebo-Controlled - Placebo Arm n=1 participants at risk The Randomized Double-Blind Placebo-Controlled (RDBPC) Analysis Set includes 1 patient treated with Placebo in the first treatment phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 participants at risk The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm n=5 participants at risk The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Screening Phase n=15 participants at risk Time from informed consent signature up to day prior to first dose of study treatment
General disorders Pyrexia	14.3% 2/14 • Number of events 4 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Hypothermia	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Haematochezia	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.

Other adverse events

Measure	Single Arm Open-Label - Tadekinig Alfa n=14 participants at risk The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.	Randomized Double-Blind Placebo-Controlled - Placebo Arm n=1 participants at risk The Randomized Double-Blind Placebo-Controlled (RDBPC) Analysis Set includes 1 patient treated with Placebo in the first treatment phase.	Randomized Withdrawal - Tadekinig Alfa Arm n=5 participants at risk The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Randomized Withdrawal - Placebo Arm n=5 participants at risk The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.	Screening Phase n=15 participants at risk Time from informed consent signature up to day prior to first dose of study treatment
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Injection site bruising	35.7% 5/14 • Number of events 41 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	40.0% 2/5 • Number of events 9 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Injection site erythema	28.6% 4/14 • Number of events 10 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Injection site pain	28.6% 4/14 • Number of events 15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	40.0% 2/5 • Number of events 5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Pyrexia	28.6% 4/14 • Number of events 10 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 3 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Asthenia	14.3% 2/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Condition aggravated	14.3% 2/14 • Number of events 3 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Fatigue	14.3% 2/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Injection site swelling	14.3% 2/14 • Number of events 4 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Hypothermia	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Inflammation	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Injection site reaction	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Peripheral swelling	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Complication associated with device	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
General disorders Secretion discharge	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 2/14 • Number of events 5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Rales	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Respiratory, thoracic and mediastinal disorders Wheezing	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Psychiatric disorders Depressed mood	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Psychiatric disorders Insomnia	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations C-reactive protein increased	28.6% 4/14 • Number of events 6 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	40.0% 2/5 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 3/15 • Number of events 3 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Red blood cell sedimentation rate increased	21.4% 3/14 • Number of events 5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	13.3% 2/15 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Alanine aminotransferase increased	14.3% 2/14 • Number of events 3 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Aspartate aminotransferase increased	14.3% 2/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Adenovirus test positive	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Blood lactate dehydrogenase increased	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	13.3% 2/15 • Number of events 3 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Coronavirus test positive	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Cytomegalovirus test positive	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Human rhinovirus test positive	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Interleukin-2 receptor increased	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Sapovirus test positive	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Serum ferritin increased	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 3/15 • Number of events 3 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Transaminases increased	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Weight decreased	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Investigations Vital signs measurement	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Injury, poisoning and procedural complications Contusion	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Injury, poisoning and procedural complications Overdose	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Injury, poisoning and procedural complications Transfusion reaction	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Injury, poisoning and procedural complications Wrist fracture	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Cardiac disorders Coronary artery dilatation	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Cardiac disorders Tachycardia	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Nervous system disorders Fontanelle bulging	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Nervous system disorders Headache	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Nervous system disorders Somnolence	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Blood and lymphatic system disorders Anaemia	14.3% 2/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Blood and lymphatic system disorders Splenomegaly	14.3% 2/14 • Number of events 3 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Blood and lymphatic system disorders Thrombocytopenia	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Ear and labyrinth disorders Ear pain	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Eye disorders Ocular hypertension	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Diarrhoea	35.7% 5/14 • Number of events 7 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Constipation	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Colitis	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Inflammatory bowel disease	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Haematochezia	28.6% 4/14 • Number of events 5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Abdominal pain	21.4% 3/14 • Number of events 6 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Abdominal distension	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Poisoning	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Frequent bowel movements	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Teething	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Dental caries	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Gastrointestinal disorders Mouth ulceration	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Hepatobiliary disorders Hepatosplenomegaly	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Skin and subcutaneous tissue disorders Rash	28.6% 4/14 • Number of events 10 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 8 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Skin and subcutaneous tissue disorders Acne	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Skin and subcutaneous tissue disorders Alopecia	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Skin and subcutaneous tissue disorders Ingrowing nail	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Skin and subcutaneous tissue disorders Macule	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Skin and subcutaneous tissue disorders Palmar erythema	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Arthralgia	21.4% 3/14 • Number of events 5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Pain in extremity	21.4% 3/14 • Number of events 4 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Groin pain	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Joint effusion	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Limb discomfort	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Muscle spasms	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Osteonecrosis	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Osteoporosis	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Musculoskeletal and connective tissue disorders Synovitis	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Clostridium difficile colitis	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Coronavirus infection	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Epstein-Barr viraemia	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Otitis media	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Tinea infection	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Localised infection	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	6.7% 1/15 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations External ear cellulitis	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Groin abscess	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Furuncle	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Hordeolum	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Respiratory tract infection	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Upper respiratory tract infection	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Subcutaneous abscess	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Urinary tract infection	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Infections and infestations Viral upper respiratory tract infection	7.1% 1/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Hypophosphataemia	14.3% 2/14 • Number of events 2 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	20.0% 1/5 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Fluid retention	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Hepatic steatosis	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/14 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	100.0% 1/1 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Hypocalcaemia	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Metabolism and nutrition disorders Hypomagnesaemia	7.1% 1/14 • Number of events 1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/1 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/5 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.	0.00% 0/15 • Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study). Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.

Additional Information

Eduardo Schiffrin

AB2 Bio Ltd.

Phone: +41 21 694 00 40

Email: eduardo.schiffrin@ab2bio.com

Results disclosure agreements

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