Trial Outcomes & Findings for Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (NCT NCT02346240)

NCT ID: NCT02346240

Last Updated: 2021-07-16

Results Overview

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 559 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2021-07-16

Participant Flow

This study started to enroll participants in February 2015, from multiple sites in Europe and United States and concluded in December 2018. 559 participants are included in the Randomized Set (RS) shown in the Participant Flow.

The study included a Screening Period, an Initial Treatment Period up to Week 16, a Maintenance Treatment Period up to Week 48, an Open-Label Extension Treatment Period up to Week 144 and a Safety Follow-up Period up to Week 157. The Participants Flow refers to the Randomized Set, the Maintenance Set and the Open Label Set.

Participant milestones

Measure	Placebo Q2W Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.	Etanercept Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	CZP 200 mg Q2W CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	CZP 400 mg Q2W CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	Placebo/Placebo Q2W This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	Etanercept/Placebo Q2W This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	Etanercept/CZP 200 mg Q2W This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).	CZP 200 mg Q2W/Placebo Q2W This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	CZP 200 mg Q2W/CZP 200 mg Q2W This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).	CZP 200 mg Q2W/CZP 400 mg Q4W This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48).	CZP 400 mg Q2W/Placebo Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	CZP 400 mg Q2W/CZP 200 mg Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).	CZP 400 mg Q2W/CZP 400 mg Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48).	Placebo Q2W/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	Etanercept/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the Etanercept arm, who did not achieve a PASI75 response at Week 16 escaped from the treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	CZP 200 mg Q2W/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the CZP 200 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	CZP 400 mg Q2W/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	Placebo/CZP 200 mg Q2W OLE This arm consisted of participants from the Placebo-controlled Maintenance Period, who achieved PASI50 response (had no relapse) at Week 48 and entered the 96-Weeks OLE Period receiving CZP 200 mg Q2W.	CZP 200 mg Q2W/CZP 200 mg Q2W OLE This arm consisted of participants who received CZP 200 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE.	CZP 400 mg Q4W/CZP 200 mg Q2W OLE This arm consisted of participants who received CZP 400 mg Q4W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose.	CZP 400 mg Q2W/CZP 200 mg Q2W OLE This arm consisted of participants who received CZP 400 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose.	Esc CZP 400 mg Q2W/CZP 400 mg Q2W OLE This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.	Placebo/CZP 400 mg Q2W OLE This arm consisted of participants from the Placebo-controlled Maintenance Period, who did not achieve PASI50 response (had relapse) and entered the 96-weeks OLE Period receiving CZP 400 mg Q2W.	Any CZP/CZP 400 mg Q2W OLE This arm consisted of participants who relapsed on CZP 200 mg Q2W, CZP 400 mg Q4W and 400 mg Q2W.
Initial Period (Baseline to Week 16) STARTED	57	170	165	167	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Completed Week 16	55	159	159	162	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Finished Wk16 Started Maintenance Period	55	159	159	160	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) COMPLETED	55	159	159	160	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) NOT COMPLETED	2	11	6	7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) STARTED	0	0	0	0	2	24	50	22	44	44	25	50	49	53	85	49	36	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Completed Maintenance Period	0	0	0	0	2	23	48	20	40	43	23	47	49	46	71	36	30	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Finished Wk48 Entered Open-label Period	0	0	0	0	2	23	48	20	40	43	23	47	49	45	68	35	29	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) COMPLETED	0	0	0	0	2	23	48	20	40	43	23	47	49	45	68	35	29	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) NOT COMPLETED	0	0	0	0	0	1	2	2	4	1	2	3	0	8	17	14	7	0	0	0	0	0	0	0
Open-Label Period (Week 48 to Week 144) STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	34	122	41	48	177	34	16
Open-Label Period (Week 48 to Week 144) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	31	105	34	45	146	27	8
Open-Label Period (Week 48 to Week 144) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	17	7	3	31	7	8

Reasons for withdrawal

Measure	Placebo Q2W Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.	Etanercept Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	CZP 200 mg Q2W CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	CZP 400 mg Q2W CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	Placebo/Placebo Q2W This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	Etanercept/Placebo Q2W This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	Etanercept/CZP 200 mg Q2W This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).	CZP 200 mg Q2W/Placebo Q2W This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	CZP 200 mg Q2W/CZP 200 mg Q2W This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).	CZP 200 mg Q2W/CZP 400 mg Q4W This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48).	CZP 400 mg Q2W/Placebo Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48).	CZP 400 mg Q2W/CZP 200 mg Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48).	CZP 400 mg Q2W/CZP 400 mg Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48).	Placebo Q2W/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	Etanercept/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the Etanercept arm, who did not achieve a PASI75 response at Week 16 escaped from the treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	CZP 200 mg Q2W/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the CZP 200 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	CZP 400 mg Q2W/Escape CZP 400 mg Q2W This arm consisted of participants initially randomized in the CZP 400 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.	Placebo/CZP 200 mg Q2W OLE This arm consisted of participants from the Placebo-controlled Maintenance Period, who achieved PASI50 response (had no relapse) at Week 48 and entered the 96-Weeks OLE Period receiving CZP 200 mg Q2W.	CZP 200 mg Q2W/CZP 200 mg Q2W OLE This arm consisted of participants who received CZP 200 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE.	CZP 400 mg Q4W/CZP 200 mg Q2W OLE This arm consisted of participants who received CZP 400 mg Q4W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose.	CZP 400 mg Q2W/CZP 200 mg Q2W OLE This arm consisted of participants who received CZP 400 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose.	Esc CZP 400 mg Q2W/CZP 400 mg Q2W OLE This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.	Placebo/CZP 400 mg Q2W OLE This arm consisted of participants from the Placebo-controlled Maintenance Period, who did not achieve PASI50 response (had relapse) and entered the 96-weeks OLE Period receiving CZP 400 mg Q2W.	Any CZP/CZP 400 mg Q2W OLE This arm consisted of participants who relapsed on CZP 200 mg Q2W, CZP 400 mg Q4W and 400 mg Q2W.
Initial Period (Baseline to Week 16) Adverse Event	0	4	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Lack of Efficacy	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Protocol Violation	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Lost to Follow-up	1	2	1	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Withdrawal by Subject	1	2	3	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Non-compliance	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Initial Period (Baseline to Week 16) Subject missed 3 visits	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Adverse Event	0	0	0	0	0	0	0	1	2	0	0	0	0	1	4	1	2	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	3	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Withdrawal by Subject	0	0	0	0	0	1	1	1	1	0	1	2	0	2	5	2	1	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Did not achieve PASI50	0	0	0	0	0	0	0	0	0	0	0	0	0	3	3	8	4	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Moved out of state	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Sponsor decision due to non-compliance	0	0	0	0	0	0	0	0	1	0	0	1	0	1	1	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Adverse events and alcohol problem	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Patient's decisions	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Unavailability due to business trip	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Withdrawn by Sponsor	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 16 to Week 48) Patient request due to non-compliance	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Open-Label Period (Week 48 to Week 144) Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	6	2	3	13	3	3
Open-Label Period (Week 48 to Week 144) Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	1	0	0
Open-Label Period (Week 48 to Week 144) Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0
Open-Label Period (Week 48 to Week 144) Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Open-Label Period (Week 48 to Week 144) Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2	3	0	1	1	1
Open-Label Period (Week 48 to Week 144) Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	1	0	10	1	1
Open-Label Period (Week 48 to Week 144) No PASI50 response	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	4	2	3
Open-Label Period (Week 48 to Week 144) No efficacy of study medication	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0

Baseline Characteristics

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)

Baseline characteristics by cohort

Measure	Placebo Q2W n=57 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.	Etanercept n=170 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	CZP 200 mg Q2W n=165 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	CZP 400 mg Q2W n=167 Participants CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.	Total Title n=559 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	156 Participants n=7 Participants	153 Participants n=5 Participants	154 Participants n=4 Participants	516 Participants n=21 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	40 Participants n=21 Participants
Age, Continuous	46.5 years STANDARD_DEVIATION 12.5 • n=5 Participants	44.6 years STANDARD_DEVIATION 14.1 • n=7 Participants	46.7 years STANDARD_DEVIATION 13.5 • n=5 Participants	45.4 years STANDARD_DEVIATION 12.4 • n=4 Participants	45.7 years STANDARD_DEVIATION 13.3 • n=21 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	43 Participants n=7 Participants	52 Participants n=5 Participants	60 Participants n=4 Participants	178 Participants n=21 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	127 Participants n=7 Participants	113 Participants n=5 Participants	107 Participants n=4 Participants	381 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized White	57 Participants n=5 Participants	163 Participants n=7 Participants	158 Participants n=5 Participants	162 Participants n=4 Participants	540 Participants n=21 Participants
Race/Ethnicity, Customized Other/mixed	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo Q2W (RS) n=57 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	Etanercept (RS) n=170 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W (RS) n=165 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 400 mg Q2W (RS) n=167 Participants CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/Placebo Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12	5.0 percentage of participants	53.3 percentage of participants	61.3 percentage of participants	66.7 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

Outcome measures

Measure	Placebo Q2W (RS) n=57 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	Etanercept (RS) n=170 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W (RS) n=165 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 400 mg Q2W (RS) n=167 Participants CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/Placebo Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12	1.9 percentage of participants	39.2 percentage of participants	39.8 percentage of participants	50.3 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo Q2W (RS) n=57 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	Etanercept (RS) n=170 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W (RS) n=165 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 400 mg Q2W (RS) n=167 Participants CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/Placebo Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12	0.2 percentage of participants	27.1 percentage of participants	31.2 percentage of participants	34.0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo Q2W (RS) n=57 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	Etanercept (RS) n=165 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W (RS) n=167 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 400 mg Q2W (RS) CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/Placebo Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16	3.8 percentage of participants	68.2 percentage of participants	74.7 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

Outcome measures

Measure	Placebo Q2W (RS) n=57 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	Etanercept (RS) n=165 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W (RS) n=167 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 400 mg Q2W (RS) CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/Placebo Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16	3.4 percentage of participants	48.3 percentage of participants	58.4 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo Q2W (RS) n=57 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	Etanercept (RS) n=165 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W (RS) n=167 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 400 mg Q2W (RS) CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/Placebo Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16	0.3 percentage of participants	39.8 percentage of participants	49.1 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: The Week 16 Randomized Set (WK16RS) consisted of all participants who achieved a PASI75 response at Week 16 and were re-randomized into the double-blind, placebo-controlled Maintenance Treatment Period. Missing data were handled using non-response imputation (NRI) methods.

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo Q2W (RS) n=2 Participants Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	Etanercept (RS) n=24 Participants Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W (RS) n=50 Participants CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 400 mg Q2W (RS) n=22 Participants CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).	CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) n=44 Participants This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) n=44 Participants This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/Placebo Q2W (WK16RS) n=25 Participants This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) n=50 Participants This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).	CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) n=49 Participants This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16	100 percentage of participants	8.3 percentage of participants	82.0 percentage of participants	45.5 percentage of participants	79.5 percentage of participants	88.6 percentage of participants	36.0 percentage of participants	80.0 percentage of participants	98.0 percentage of participants

Adverse Events

Placebo Q2W (SS) Wk 0-48

Serious events: 8 serious events

Other events: 42 other events

Deaths: 0 deaths

Etanercept (SS) Wk 0-12

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

CZP 200 mg Q2W (SS) Wk 0-144

Serious events: 34 serious events

Other events: 139 other events

Deaths: 2 deaths

CZP 400 mg Q2W (SS) Wk 0-144

Serious events: 51 serious events

Other events: 158 other events

Deaths: 1 deaths

CZP 400mg Q4W (SS) Wk 16-48

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Q2W (SS) Wk 0-48 n=128 participants at risk This arm consisted of all participants who received Placebo (PBO) at any time in the study (Week 0 to Week 48). Only 2 participants received PBO from Week 16 to Week 48. Participants formed the Safety Set (SS).	Etanercept (SS) Wk 0-12 n=168 participants at risk This arm consisted of all participants who received Etanercept at any time in the study (Week 0 to Week 12). Participants formed the SS.	CZP 200 mg Q2W (SS) Wk 0-144 n=373 participants at risk This arm consisted of all participants who received CZP 200 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.	CZP 400 mg Q2W (SS) Wk 0-144 n=412 participants at risk This arm consisted of all participants who received CZP 400 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.	CZP 400mg Q4W (SS) Wk 16-48 n=44 participants at risk This arm consisted of all participants who received CZP 400 mg Q4W at any time in the study (Week 16 to Week 48). Participants formed the SS.
Cardiac disorders Intracardiac mass	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Cardiac disorders Coronary artery disease	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Cardiac disorders Cardiac failure	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Cardiac disorders Acute coronary syndrome	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Cardiac disorders Acute myocardial infarction	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Cardiac disorders Angina pectoris	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Eye disorders Cataract	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Eye disorders Retinal detachment	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Large intestine polyp	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Crohn's disease	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Abdominal pain	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Haemorrhoids	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Inguinal hernia	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.3% 1/44 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Peptic ulcer	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Gastrointestinal disorders Umbilical hernia	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
General disorders Inflammation	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
General disorders Systemic inflammatory response syndrome	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
General disorders Nodule	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
General disorders Vascular stent thrombosis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Hepatobiliary disorders Cholecystitis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Hepatobiliary disorders Liver disorder	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Hepatobiliary disorders Hepatitis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Immune system disorders Sarcoidosis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Immune system disorders House dust allergy	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Appendiceal abscess	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Appendicitis perforated	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Gastroenteritis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Pancreas infection	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.3% 1/44 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Rectal abscess	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Cellulitis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Osteomyelitis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Pseudomembranous colitis	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Escherichia sepsis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Endophthalmitis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Pneumonia klebsiella	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Pneumonia	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.49% 2/412 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.3% 1/44 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Bronchitis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Bacteraemia	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Sepsis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Pyoderma	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Subcutaneous abscess	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Erysipelas	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Tuberculosis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Pyelonephritis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Concussion	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.49% 2/412 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.3% 1/44 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Ulna fracture	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Laceration	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Investigations Hepatic enzyme increased	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Investigations Mycobacterium tuberculosis complex test negative	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Investigations Blood creatine phosphokinase increased	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Metabolism and nutrition disorders Obesity	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Back pain	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.80% 3/373 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.3% 1/44 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic oligodendroglioma	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Syncope	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Nervous system disorders Migraine	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.49% 2/412 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Nervous system disorders Primary progressive multiple sclerosis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Pregnancy, puerperium and perinatal conditions Pregnancy on contraceptive	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Psychiatric disorders Bipolar I disorder	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Psychiatric disorders Depression	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Renal and urinary disorders Acute kidney injury	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Renal and urinary disorders Nephrolithiasis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Renal and urinary disorders Renal cyst	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Reproductive system and breast disorders Cervical polyp	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Reproductive system and breast disorders Metrorrhagia	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Reproductive system and breast disorders Rectocele	0.78% 1/128 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Reproductive system and breast disorders Uterine cyst	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Reproductive system and breast disorders Uterine polyp	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.54% 2/373 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Skin and subcutaneous tissue disorders Guttate psoriasis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.27% 1/373 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/412 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Vascular disorders Hypertensive crisis	0.00% 0/128 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/168 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/373 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.24% 1/412 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.00% 0/44 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.

Other adverse events

Measure	Placebo Q2W (SS) Wk 0-48 n=128 participants at risk This arm consisted of all participants who received Placebo (PBO) at any time in the study (Week 0 to Week 48). Only 2 participants received PBO from Week 16 to Week 48. Participants formed the Safety Set (SS).	Etanercept (SS) Wk 0-12 n=168 participants at risk This arm consisted of all participants who received Etanercept at any time in the study (Week 0 to Week 12). Participants formed the SS.	CZP 200 mg Q2W (SS) Wk 0-144 n=373 participants at risk This arm consisted of all participants who received CZP 200 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.	CZP 400 mg Q2W (SS) Wk 0-144 n=412 participants at risk This arm consisted of all participants who received CZP 400 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.	CZP 400mg Q4W (SS) Wk 16-48 n=44 participants at risk This arm consisted of all participants who received CZP 400 mg Q4W at any time in the study (Week 16 to Week 48). Participants formed the SS.
Infections and infestations Nasopharyngitis	11.7% 15/128 • Number of events 16 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	8.3% 14/168 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	15.0% 56/373 • Number of events 81 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	16.0% 66/412 • Number of events 83 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	6.8% 3/44 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Upper respiratory tract infection	10.2% 13/128 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	7.1% 12/168 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	10.2% 38/373 • Number of events 55 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	10.9% 45/412 • Number of events 64 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	6.8% 3/44 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Infections and infestations Viral upper respiratory tract infection	1.6% 2/128 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.4% 4/168 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	6.2% 23/373 • Number of events 34 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.7% 11/412 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	4.5% 2/44 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Investigations Blood creatine phosphokinase increased	1.6% 2/128 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	1.2% 2/168 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.4% 9/373 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.9% 12/412 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	6.8% 3/44 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 3/128 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	1.8% 3/168 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	3.8% 14/373 • Number of events 17 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	4.4% 18/412 • Number of events 20 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	6.8% 3/44 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Skin and subcutaneous tissue disorders Psoriasis	5.5% 7/128 • Number of events 7 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.7% 10/373 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	4.9% 20/412 • Number of events 23 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	2.3% 1/44 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
Vascular disorders Hypertension	5.5% 7/128 • Number of events 7 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	1.8% 3/168 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	5.1% 19/373 • Number of events 19 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	5.8% 24/412 • Number of events 24 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.	4.5% 2/44 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144. At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.

Additional Information

UCB

Cares

Phone: +1844 599

Email: UCBCares@ucb.com

Results disclosure agreements

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

Restriction type: GT60