Trial Outcomes & Findings for A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics (NCT NCT02960490)

Last Updated: 2021-08-23

Results Overview

The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (\>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); \>=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale \[VAS\]), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability index (HAQ-DI), and C-reactive protein (CRP).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

Week 12

Results posted on

2021-08-23

Participant Flow

Participants took part in the study at 46 investigative sites in Japan from 26 November 2016 to 25 November 2019.

A total of 93 participants were screened, of which 66 were randomized to receive study treatment. This study has a Core Treatment Phase (Treatment Phase: 12 Weeks; Entire Treatment Phase \[Re-randomized Participants\]: 12 Weeks) and an Extension Phase: 80 Weeks.

Participant milestones

Participant milestones
Measure	Core Treatment Phase: Placebo During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg During the Core Treatment Phase, participants received E6011 400 milligram (mg), infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: Placebo Then E6011 200 mg Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: Placebo Then E6011 400 mg Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Treatment Phase(Double-blind): 12 Weeks STARTED	34	32	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks Treated	33	31	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks Full Analysis Set (FAS)	33	31	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks Safety Analysis Set (SAS)	33	31	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks COMPLETED	29	26	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks NOT COMPLETED	5	6	0	0	0	0	0	0	0	0
Re-randomized Participants: 12 Weeks STARTED	0	0	15	14	14	12	0	0	0	0
Re-randomized Participants: 12 Weeks Treated	0	0	15	14	14	12	0	0	0	0
Re-randomized Participants: 12 Weeks FAS	0	0	15	14	14	12	0	0	0	0
Re-randomized Participants: 12 Weeks SAS	0	0	15	14	14	12	0	0	0	0
Re-randomized Participants: 12 Weeks COMPLETED	0	0	13	12	13	10	0	0	0	0
Re-randomized Participants: 12 Weeks NOT COMPLETED	0	0	2	2	1	2	0	0	0	0
Extension Phase(Open-label): 80 Weeks STARTED	0	0	0	0	0	0	13	11	13	10
Extension Phase(Open-label): 80 Weeks Treated	0	0	0	0	0	0	13	11	13	10
Extension Phase(Open-label): 80 Weeks FAS	0	0	0	0	0	0	13	11	13	10
Extension Phase(Open-label): 80 Weeks SAS	0	0	0	0	0	0	13	11	13	10
Extension Phase(Open-label): 80 Weeks COMPLETED	0	0	0	0	0	0	4	5	9	3
Extension Phase(Open-label): 80 Weeks NOT COMPLETED	0	0	0	0	0	0	9	6	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Core Treatment Phase: Placebo During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg During the Core Treatment Phase, participants received E6011 400 milligram (mg), infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: Placebo Then E6011 200 mg Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: Placebo Then E6011 400 mg Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Treatment Phase(Double-blind): 12 Weeks Lack of Efficacy	3	2	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks Adverse Event	0	1	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks Disease Progression	1	2	0	0	0	0	0	0	0	0
Treatment Phase(Double-blind): 12 Weeks Not treated	1	1	0	0	0	0	0	0	0	0
Re-randomized Participants: 12 Weeks Lack of Efficacy	0	0	1	1	0	2	0	0	0	0
Re-randomized Participants: 12 Weeks Adverse Event	0	0	1	0	1	0	0	0	0	0
Re-randomized Participants: 12 Weeks Other	0	0	0	1	0	0	0	0	0	0
Extension Phase(Open-label): 80 Weeks Adverse Event	0	0	0	0	0	0	3	1	1	0
Extension Phase(Open-label): 80 Weeks Withdrawal by Subject	0	0	0	0	0	0	0	1	0	0
Extension Phase(Open-label): 80 Weeks Lack of Efficacy	0	0	0	0	0	0	4	3	3	7
Extension Phase(Open-label): 80 Weeks Disease Progression	0	0	0	0	0	0	2	0	0	0
Extension Phase(Open-label): 80 Weeks Other	0	0	0	0	0	0	0	1	0	0

Baseline Characteristics

A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Core Treatment Phase: Placebo n=33 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (Placebo) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg n=31 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (E6011 400 mg) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Total n=64 Participants Total of all reporting groups
Age, Continuous	49.6 years STANDARD_DEVIATION 10.64 • n=5 Participants	53.5 years STANDARD_DEVIATION 11.30 • n=7 Participants	51.5 years STANDARD_DEVIATION 11.05 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: FAS included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=33 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=31 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI)	27.3 percentage of participants Interval 12.08 to 42.47	22.6 percentage of participants Interval 7.86 to 37.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 16, 20, 24; Extension Phase: Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.

The ACR20 response was defined as if the following 3 criteria (ACR components) were met: \>=20% reduction from baseline in the TJC in 68 joints (TJC68); \>=20% reduction from baseline in the SJC in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 8	20.0 percentage of participants Interval 0.0 to 40.24	28.6 percentage of participants Interval 4.91 to 52.24	35.7 percentage of participants Interval 10.61 to 60.81	25.0 percentage of participants Interval 0.5 to 49.5	23.1 percentage of participants Interval 0.17 to 45.98	27.3 percentage of participants Interval 0.95 to 53.59	38.5 percentage of participants Interval 12.02 to 64.91	30.0 percentage of participants Interval 1.6 to 58.4
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 16	26.7 percentage of participants Interval 4.29 to 49.05	28.6 percentage of participants Interval 4.91 to 52.24	42.9 percentage of participants Interval 16.93 to 68.78	50.0 percentage of participants Interval 21.71 to 78.29	30.8 percentage of participants Interval 5.68 to 55.86	36.4 percentage of participants Interval 7.94 to 64.79	46.2 percentage of participants Interval 19.05 to 73.25	60.0 percentage of participants Interval 29.64 to 90.36
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 20	46.7 percentage of participants Interval 21.42 to 71.91	35.7 percentage of participants Interval 10.61 to 60.81	28.6 percentage of participants Interval 4.91 to 52.24	50.0 percentage of participants Interval 21.71 to 78.29	53.8 percentage of participants Interval 26.75 to 80.95	45.5 percentage of participants Interval 16.03 to 74.88	30.8 percentage of participants Interval 5.68 to 55.86	50.0 percentage of participants Interval 19.01 to 80.99
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 32	—	—	—	—	61.5 percentage of participants Interval 35.09 to 87.98	36.4 percentage of participants Interval 7.94 to 64.79	38.5 percentage of participants Interval 12.02 to 64.91	50.0 percentage of participants Interval 19.01 to 80.99
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 36	—	—	—	—	46.2 percentage of participants Interval 19.05 to 73.25	36.4 percentage of participants Interval 7.94 to 64.79	38.5 percentage of participants Interval 12.02 to 64.91	50.0 percentage of participants Interval 19.01 to 80.99
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 40	—	—	—	—	61.5 percentage of participants Interval 35.09 to 87.98	36.4 percentage of participants Interval 7.94 to 64.79	30.8 percentage of participants Interval 5.68 to 55.86	40.0 percentage of participants Interval 9.64 to 70.36
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 44	—	—	—	—	61.5 percentage of participants Interval 35.09 to 87.98	45.5 percentage of participants Interval 16.03 to 74.88	38.5 percentage of participants Interval 12.02 to 64.91	40.0 percentage of participants Interval 9.64 to 70.36
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 48	—	—	—	—	53.8 percentage of participants Interval 26.75 to 80.95	54.5 percentage of participants Interval 25.12 to 83.97	53.8 percentage of participants Interval 26.75 to 80.95	40.0 percentage of participants Interval 9.64 to 70.36
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 52	—	—	—	—	38.5 percentage of participants Interval 12.02 to 64.91	45.5 percentage of participants Interval 16.03 to 74.88	53.8 percentage of participants Interval 26.75 to 80.95	50.0 percentage of participants Interval 19.01 to 80.99
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 2	13.3 percentage of participants Interval 0.0 to 30.54	7.1 percentage of participants Interval 0.0 to 20.63	7.1 percentage of participants Interval 0.0 to 20.63	25.0 percentage of participants Interval 0.5 to 49.5	15.4 percentage of participants Interval 0.0 to 35.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 4	13.3 percentage of participants Interval 0.0 to 30.54	28.6 percentage of participants Interval 4.91 to 52.24	28.6 percentage of participants Interval 4.91 to 52.24	8.3 percentage of participants Interval 0.0 to 23.97	15.4 percentage of participants Interval 0.0 to 35.0	27.3 percentage of participants Interval 0.95 to 53.59	30.8 percentage of participants Interval 5.68 to 55.86	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 24	46.7 percentage of participants Interval 21.42 to 71.91	28.6 percentage of participants Interval 4.91 to 52.24	21.4 percentage of participants Interval 0.0 to 42.92	33.3 percentage of participants Interval 6.66 to 60.01	53.8 percentage of participants Interval 26.75 to 80.95	36.4 percentage of participants Interval 7.94 to 64.79	23.1 percentage of participants Interval 0.17 to 45.98	30.0 percentage of participants Interval 1.6 to 58.4
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 28	—	—	—	—	53.8 percentage of participants Interval 26.75 to 80.95	54.5 percentage of participants Interval 25.12 to 83.97	38.5 percentage of participants Interval 12.02 to 64.91	50.0 percentage of participants Interval 19.01 to 80.99
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 72	—	—	—	—	38.5 percentage of participants Interval 12.02 to 64.91	45.5 percentage of participants Interval 16.03 to 74.88	53.8 percentage of participants Interval 26.75 to 80.95	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 56	—	—	—	—	53.8 percentage of participants Interval 26.75 to 80.95	27.3 percentage of participants Interval 0.95 to 53.59	38.5 percentage of participants Interval 12.02 to 64.91	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 60	—	—	—	—	46.2 percentage of participants Interval 19.05 to 73.25	18.2 percentage of participants Interval 0.0 to 40.97	38.5 percentage of participants Interval 12.02 to 64.91	30.0 percentage of participants Interval 1.6 to 58.4
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 64	—	—	—	—	46.2 percentage of participants Interval 19.05 to 73.25	27.3 percentage of participants Interval 0.95 to 53.59	46.2 percentage of participants Interval 19.05 to 73.25	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 68	—	—	—	—	38.5 percentage of participants Interval 12.02 to 64.91	27.3 percentage of participants Interval 0.95 to 53.59	38.5 percentage of participants Interval 12.02 to 64.91	20.0 percentage of participants Interval 0.0 to 44.79

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The ACR50 response was defined as if the following 3 criteria (ACR components) were met: \>=50% reduction from baseline in the TJC in 68 joints (TJC68); \>=50% reduction from baseline in the SJC in 66 joints (SJC66); \>=50% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 2	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 16	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	16.7 percentage of participants Interval 0.0 to 37.75	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 20	20.0 percentage of participants Interval 0.0 to 40.24	7.1 percentage of participants Interval 0.0 to 20.63	7.1 percentage of participants Interval 0.0 to 20.63	16.7 percentage of participants Interval 0.0 to 37.75	23.1 percentage of participants Interval 0.17 to 45.98	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 24	20.0 percentage of participants Interval 0.0 to 40.24	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	16.7 percentage of participants Interval 0.0 to 37.75	23.1 percentage of participants Interval 0.17 to 45.98	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 28	—	—	—	—	30.8 percentage of participants Interval 5.68 to 55.86	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	30.0 percentage of participants Interval 1.6 to 58.4
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 32	—	—	—	—	15.4 percentage of participants Interval 0.0 to 35.0	9.1 percentage of participants Interval 0.0 to 26.08	30.8 percentage of participants Interval 5.68 to 55.86	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 36	—	—	—	—	23.1 percentage of participants Interval 0.17 to 45.98	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 40	—	—	—	—	15.4 percentage of participants Interval 0.0 to 35.0	9.1 percentage of participants Interval 0.0 to 26.08	23.1 percentage of participants Interval 0.17 to 45.98	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 44	—	—	—	—	30.8 percentage of participants Interval 5.68 to 55.86	27.3 percentage of participants Interval 0.95 to 53.59	23.1 percentage of participants Interval 0.17 to 45.98	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 48	—	—	—	—	23.1 percentage of participants Interval 0.17 to 45.98	27.3 percentage of participants Interval 0.95 to 53.59	30.8 percentage of participants Interval 5.68 to 55.86	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 52	—	—	—	—	15.4 percentage of participants Interval 0.0 to 35.0	27.3 percentage of participants Interval 0.95 to 53.59	30.8 percentage of participants Interval 5.68 to 55.86	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 56	—	—	—	—	23.1 percentage of participants Interval 0.17 to 45.98	18.2 percentage of participants Interval 0.0 to 40.97	23.1 percentage of participants Interval 0.17 to 45.98	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 60	—	—	—	—	30.8 percentage of participants Interval 5.68 to 55.86	18.2 percentage of participants Interval 0.0 to 40.97	30.8 percentage of participants Interval 5.68 to 55.86	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 64	—	—	—	—	23.1 percentage of participants Interval 0.17 to 45.98	18.2 percentage of participants Interval 0.0 to 40.97	23.1 percentage of participants Interval 0.17 to 45.98	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 68	—	—	—	—	23.1 percentage of participants Interval 0.17 to 45.98	9.1 percentage of participants Interval 0.0 to 26.08	23.1 percentage of participants Interval 0.17 to 45.98	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 72	—	—	—	—	15.4 percentage of participants Interval 0.0 to 35.0	27.3 percentage of participants Interval 0.95 to 53.59	30.8 percentage of participants Interval 5.68 to 55.86	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.0 to 32.62	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 8	0.0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.0 to 32.62	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 12	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	7.1 percentage of participants Interval 0.0 to 20.63	16.7 percentage of participants Interval 0.0 to 37.75	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	20.0 percentage of participants Interval 0.0 to 44.79

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The ACR70 response was defined as if the following 3 criteria (ACR components) were met: \>=70% reduction from baseline in the TJC in 68 joints (TJC68); \>=70% reduction from baseline in the SJC in 66 joints (SJC66); \>=70% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 2	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 8	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 12	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 16	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 20	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	8.3 percentage of participants Interval 0.0 to 23.97	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 24	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 28	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 32	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 36	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 40	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 44	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	18.2 percentage of participants Interval 0.0 to 40.97	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 48	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 52	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 56	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 60	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 64	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 68	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Response at Week 72	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

A total of 28 joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Tender joints were marked with tick or cross in corresponding frames of the Assessment Sheet for Tender Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Baseline	9.7 tender joints Standard Deviation 6.88	11.7 tender joints Standard Deviation 7.74	9.9 tender joints Standard Deviation 4.80	12.8 tender joints Standard Deviation 7.58	8.7 tender joints Standard Deviation 4.85	11.6 tender joints Standard Deviation 8.67	9.5 tender joints Standard Deviation 4.75	10.3 tender joints Standard Deviation 5.10
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 40	—	—	—	—	-3.8 tender joints Standard Deviation 7.16	-5.1 tender joints Standard Deviation 8.56	-3.2 tender joints Standard Deviation 7.72	-4.1 tender joints Standard Deviation 6.72
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 68	—	—	—	—	-2.8 tender joints Standard Deviation 6.72	-4.6 tender joints Standard Deviation 8.03	-2.9 tender joints Standard Deviation 8.20	-4.1 tender joints Standard Deviation 7.05
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 72	—	—	—	—	-2.8 tender joints Standard Deviation 6.65	-5.5 tender joints Standard Deviation 9.03	-3.5 tender joints Standard Deviation 8.33	-4.1 tender joints Standard Deviation 7.46
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 2	-1.6 tender joints Standard Deviation 3.92	-1.3 tender joints Standard Deviation 3.41	-1.9 tender joints Standard Deviation 4.48	-4.4 tender joints Standard Deviation 5.52	-2.0 tender joints Standard Deviation 4.06	-1.3 tender joints Standard Deviation 3.77	-2.0 tender joints Standard Deviation 4.65	-3.0 tender joints Standard Deviation 4.83
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 4	-2.8 tender joints Standard Deviation 6.07	-2.9 tender joints Standard Deviation 5.11	-2.3 tender joints Standard Deviation 5.81	-5.1 tender joints Standard Deviation 6.16	-3.2 tender joints Standard Deviation 6.48	-3.1 tender joints Standard Deviation 5.74	-1.8 tender joints Standard Deviation 5.80	-3.9 tender joints Standard Deviation 5.92
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 8	-3.3 tender joints Standard Deviation 5.51	-2.9 tender joints Standard Deviation 8.89	-1.9 tender joints Standard Deviation 6.18	-5.8 tender joints Standard Deviation 3.05	-3.5 tender joints Standard Deviation 5.91	-3.8 tender joints Standard Deviation 9.72	-1.3 tender joints Standard Deviation 6.06	-5.2 tender joints Standard Deviation 2.97
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 12	-2.7 tender joints Standard Deviation 5.59	-2.1 tender joints Standard Deviation 8.75	-2.0 tender joints Standard Deviation 6.11	-6.2 tender joints Standard Deviation 3.86	-3.1 tender joints Standard Deviation 5.92	-3.5 tender joints Standard Deviation 9.05	-1.8 tender joints Standard Deviation 6.30	-6.1 tender joints Standard Deviation 4.20
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 16	-4.3 tender joints Standard Deviation 6.65	-4.1 tender joints Standard Deviation 5.17	-2.9 tender joints Standard Deviation 5.73	-7.5 tender joints Standard Deviation 6.97	-4.5 tender joints Standard Deviation 7.15	-4.8 tender joints Standard Deviation 5.38	-2.6 tender joints Standard Deviation 5.84	-6.5 tender joints Standard Deviation 5.72
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 20	-4.9 tender joints Standard Deviation 6.06	-4.1 tender joints Standard Deviation 7.19	-2.9 tender joints Standard Deviation 6.46	-8.2 tender joints Standard Deviation 7.30	-5.2 tender joints Standard Deviation 6.48	-4.9 tender joints Standard Deviation 7.82	-2.8 tender joints Standard Deviation 6.72	-6.3 tender joints Standard Deviation 4.16
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 24	-5.1 tender joints Standard Deviation 5.63	-3.7 tender joints Standard Deviation 8.30	-2.6 tender joints Standard Deviation 6.06	-7.8 tender joints Standard Deviation 8.07	-5.5 tender joints Standard Deviation 5.99	-3.9 tender joints Standard Deviation 9.81	-2.5 tender joints Standard Deviation 6.29	-6.2 tender joints Standard Deviation 6.89
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 28	—	—	—	—	-4.6 tender joints Standard Deviation 6.64	-4.5 tender joints Standard Deviation 10.32	-2.4 tender joints Standard Deviation 7.54	-4.7 tender joints Standard Deviation 4.69
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 32	—	—	—	—	-3.7 tender joints Standard Deviation 7.16	-3.9 tender joints Standard Deviation 9.08	-3.5 tender joints Standard Deviation 8.42	-5.3 tender joints Standard Deviation 6.52
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 36	—	—	—	—	-4.7 tender joints Standard Deviation 7.04	-5.0 tender joints Standard Deviation 8.93	-3.5 tender joints Standard Deviation 7.61	-4.5 tender joints Standard Deviation 8.10
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 44	—	—	—	—	-4.5 tender joints Standard Deviation 7.17	-5.5 tender joints Standard Deviation 8.99	-3.6 tender joints Standard Deviation 7.89	-4.4 tender joints Standard Deviation 8.29
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 48	—	—	—	—	-4.2 tender joints Standard Deviation 7.32	-5.5 tender joints Standard Deviation 9.37	-2.9 tender joints Standard Deviation 7.71	-2.9 tender joints Standard Deviation 6.72
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 52	—	—	—	—	-2.5 tender joints Standard Deviation 6.83	-5.8 tender joints Standard Deviation 9.90	-3.8 tender joints Standard Deviation 7.93	-4.9 tender joints Standard Deviation 6.94
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 56	—	—	—	—	-2.8 tender joints Standard Deviation 6.88	-6.3 tender joints Standard Deviation 10.25	-2.8 tender joints Standard Deviation 8.00	-4.5 tender joints Standard Deviation 7.59
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 60	—	—	—	—	-2.8 tender joints Standard Deviation 6.80	-4.5 tender joints Standard Deviation 7.33	-3.5 tender joints Standard Deviation 8.12	-4.5 tender joints Standard Deviation 7.74
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 64	—	—	—	—	-2.6 tender joints Standard Deviation 6.79	-2.6 tender joints Standard Deviation 6.41	-4.1 tender joints Standard Deviation 8.27	-4.4 tender joints Standard Deviation 7.52

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

A total of 28 joints were examined for swollen joints. Swollen joints were marked with open circles in corresponding frames of the Assessment Sheet for Swollen Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 12	-2.9 swollen joints Standard Deviation 3.95	-4.2 swollen joints Standard Deviation 6.40	-2.5 swollen joints Standard Deviation 4.01	-4.3 swollen joints Standard Deviation 4.61	-3.5 swollen joints Standard Deviation 3.95	-4.5 swollen joints Standard Deviation 7.22	-2.8 swollen joints Standard Deviation 4.04	-4.2 swollen joints Standard Deviation 4.83
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Baseline	7.1 swollen joints Standard Deviation 2.91	9.5 swollen joints Standard Deviation 6.14	8.9 swollen joints Standard Deviation 3.47	8.8 swollen joints Standard Deviation 4.39	7.0 swollen joints Standard Deviation 2.97	9.5 swollen joints Standard Deviation 6.98	9.2 swollen joints Standard Deviation 3.51	7.6 swollen joints Standard Deviation 3.37
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 4	-2.3 swollen joints Standard Deviation 3.73	-3.7 swollen joints Standard Deviation 3.95	-1.8 swollen joints Standard Deviation 3.60	-3.9 swollen joints Standard Deviation 4.14	-2.4 swollen joints Standard Deviation 3.75	-3.5 swollen joints Standard Deviation 4.44	-1.9 swollen joints Standard Deviation 3.71	-3.9 swollen joints Standard Deviation 4.48
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 8	-3.3 swollen joints Standard Deviation 3.33	-4.8 swollen joints Standard Deviation 6.38	-0.8 swollen joints Standard Deviation 4.54	-4.8 swollen joints Standard Deviation 4.15	-3.5 swollen joints Standard Deviation 3.33	-5.1 swollen joints Standard Deviation 7.20	-0.8 swollen joints Standard Deviation 4.72	-5.0 swollen joints Standard Deviation 4.57
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 2	-2.7 swollen joints Standard Deviation 2.99	-2.6 swollen joints Standard Deviation 2.31	-2.0 swollen joints Standard Deviation 2.86	-3.3 swollen joints Standard Deviation 4.69	-2.7 swollen joints Standard Deviation 3.17	-2.7 swollen joints Standard Deviation 2.57	-2.2 swollen joints Standard Deviation 2.91	-2.6 swollen joints Standard Deviation 4.77
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 16	-3.2 swollen joints Standard Deviation 4.06	-5.4 swollen joints Standard Deviation 5.45	-1.9 swollen joints Standard Deviation 4.57	-5.3 swollen joints Standard Deviation 4.63	-3.5 swollen joints Standard Deviation 3.95	-5.6 swollen joints Standard Deviation 6.17	-1.9 swollen joints Standard Deviation 4.75	-5.1 swollen joints Standard Deviation 4.75
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 20	-3.3 swollen joints Standard Deviation 4.60	-5.8 swollen joints Standard Deviation 6.10	-1.4 swollen joints Standard Deviation 4.82	-5.8 swollen joints Standard Deviation 4.34	-3.2 swollen joints Standard Deviation 4.76	-6.0 swollen joints Standard Deviation 6.65	-1.4 swollen joints Standard Deviation 4.82	-5.5 swollen joints Standard Deviation 4.22
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 24	-3.9 swollen joints Standard Deviation 4.45	-5.4 swollen joints Standard Deviation 7.26	-0.6 swollen joints Standard Deviation 5.65	-4.0 swollen joints Standard Deviation 3.79	-4.4 swollen joints Standard Deviation 4.33	-4.9 swollen joints Standard Deviation 8.97	-0.8 swollen joints Standard Deviation 5.83	-4.1 swollen joints Standard Deviation 4.18
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-4.1 swollen joints Standard Deviation 3.95	-5.6 swollen joints Standard Deviation 7.85	-1.1 swollen joints Standard Deviation 5.63	-4.6 swollen joints Standard Deviation 2.84
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-3.7 swollen joints Standard Deviation 3.43	-5.3 swollen joints Standard Deviation 7.99	-1.1 swollen joints Standard Deviation 6.50	-4.5 swollen joints Standard Deviation 5.28
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-3.7 swollen joints Standard Deviation 3.75	-5.7 swollen joints Standard Deviation 7.67	-1.2 swollen joints Standard Deviation 6.95	-3.7 swollen joints Standard Deviation 6.67
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-3.5 swollen joints Standard Deviation 3.64	-5.5 swollen joints Standard Deviation 7.94	-2.8 swollen joints Standard Deviation 7.01	-3.8 swollen joints Standard Deviation 6.58
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-2.5 swollen joints Standard Deviation 6.65	-5.6 swollen joints Standard Deviation 7.84	-1.8 swollen joints Standard Deviation 7.00	-2.8 swollen joints Standard Deviation 6.55
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-3.5 swollen joints Standard Deviation 3.41	-5.5 swollen joints Standard Deviation 8.18	-2.0 swollen joints Standard Deviation 6.43	-3.1 swollen joints Standard Deviation 5.84
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-2.4 swollen joints Standard Deviation 4.03	-4.9 swollen joints Standard Deviation 8.58	-1.5 swollen joints Standard Deviation 6.57	-4.3 swollen joints Standard Deviation 6.52
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-2.8 swollen joints Standard Deviation 4.12	-5.1 swollen joints Standard Deviation 8.70	-2.1 swollen joints Standard Deviation 6.51	-3.7 swollen joints Standard Deviation 6.68
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-2.8 swollen joints Standard Deviation 4.16	-4.3 swollen joints Standard Deviation 7.93	-2.7 swollen joints Standard Deviation 7.25	-4.1 swollen joints Standard Deviation 6.49
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-2.5 swollen joints Standard Deviation 3.93	-4.0 swollen joints Standard Deviation 7.89	-1.8 swollen joints Standard Deviation 7.56	-3.6 swollen joints Standard Deviation 6.77
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-2.8 swollen joints Standard Deviation 4.13	-4.0 swollen joints Standard Deviation 8.31	-1.6 swollen joints Standard Deviation 6.95	-3.4 swollen joints Standard Deviation 6.57
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-2.7 swollen joints Standard Deviation 4.03	-4.5 swollen joints Standard Deviation 9.11	-2.6 swollen joints Standard Deviation 7.31	-3.1 swollen joints Standard Deviation 6.56

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Intensity and severity of pain associated with rheumatoid arthritis (RA) were indicated by the participant on a score sheet, Pain/disease activity assessments reported by the participant, by placing a mark on a 100 millimeter (mm) horizontal VAS. Pain assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 4	-9.8 millimeter Standard Deviation 16.50	-13.4 millimeter Standard Deviation 26.58	-8.4 millimeter Standard Deviation 21.23	-6.3 millimeter Standard Deviation 17.61	-11.2 millimeter Standard Deviation 17.32	-12.0 millimeter Standard Deviation 27.40	-7.5 millimeter Standard Deviation 21.82	-8.8 millimeter Standard Deviation 18.18
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Baseline	56.7 millimeter Standard Deviation 32.02	55.9 millimeter Standard Deviation 30.33	56.9 millimeter Standard Deviation 33.07	60.3 millimeter Standard Deviation 20.78	57.5 millimeter Standard Deviation 28.43	52.5 millimeter Standard Deviation 29.96	54.2 millimeter Standard Deviation 32.67	56.4 millimeter Standard Deviation 18.78
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 2	-5.7 millimeter Standard Deviation 15.50	-3.3 millimeter Standard Deviation 15.47	-3.3 millimeter Standard Deviation 22.53	-4.8 millimeter Standard Deviation 19.07	-7.4 millimeter Standard Deviation 15.71	-3.4 millimeter Standard Deviation 17.57	-3.0 millimeter Standard Deviation 23.42	-1.9 millimeter Standard Deviation 19.67
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 8	-13.9 millimeter Standard Deviation 18.95	-14.2 millimeter Standard Deviation 30.92	-9.6 millimeter Standard Deviation 21.94	-12.6 millimeter Standard Deviation 14.88	-14.7 millimeter Standard Deviation 19.04	-12.8 millimeter Standard Deviation 34.33	-7.5 millimeter Standard Deviation 21.19	-14.1 millimeter Standard Deviation 15.81
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 12	-8.5 millimeter Standard Deviation 25.01	-8.0 millimeter Standard Deviation 24.10	-15.1 millimeter Standard Deviation 18.89	-16.8 millimeter Standard Deviation 20.23	-9.5 millimeter Standard Deviation 23.09	-7.6 millimeter Standard Deviation 26.27	-14.2 millimeter Standard Deviation 19.33	-16.4 millimeter Standard Deviation 18.84
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 16	-15.7 millimeter Standard Deviation 23.03	-9.8 millimeter Standard Deviation 18.35	-18.5 millimeter Standard Deviation 22.70	-15.9 millimeter Standard Deviation 14.77	-16.4 millimeter Standard Deviation 24.02	-11.4 millimeter Standard Deviation 20.57	-17.8 millimeter Standard Deviation 23.49	-14.7 millimeter Standard Deviation 12.96
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 20	-18.4 millimeter Standard Deviation 28.02	-9.2 millimeter Standard Deviation 15.57	-14.7 millimeter Standard Deviation 23.67	-17.7 millimeter Standard Deviation 16.88	-22.8 millimeter Standard Deviation 23.35	-9.5 millimeter Standard Deviation 16.32	-15.0 millimeter Standard Deviation 24.61	-14.2 millimeter Standard Deviation 13.38
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 24	-17.4 millimeter Standard Deviation 27.91	-8.4 millimeter Standard Deviation 18.57	-20.0 millimeter Standard Deviation 28.15	-14.9 millimeter Standard Deviation 14.69	-21.6 millimeter Standard Deviation 23.42	-9.9 millimeter Standard Deviation 20.54	-20.7 millimeter Standard Deviation 29.18	-12.9 millimeter Standard Deviation 14.65
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-21.0 millimeter Standard Deviation 31.09	-11.4 millimeter Standard Deviation 21.87	-21.8 millimeter Standard Deviation 22.14	-13.3 millimeter Standard Deviation 21.07
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-18.5 millimeter Standard Deviation 28.19	-10.2 millimeter Standard Deviation 22.65	-18.9 millimeter Standard Deviation 31.30	-13.9 millimeter Standard Deviation 18.53
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-19.4 millimeter Standard Deviation 30.09	-14.1 millimeter Standard Deviation 29.22	-16.0 millimeter Standard Deviation 31.43	-14.1 millimeter Standard Deviation 17.95
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-19.5 millimeter Standard Deviation 25.19	-10.5 millimeter Standard Deviation 28.04	-16.6 millimeter Standard Deviation 27.97	-10.3 millimeter Standard Deviation 17.97
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-22.6 millimeter Standard Deviation 28.54	-15.1 millimeter Standard Deviation 35.60	-18.2 millimeter Standard Deviation 29.42	-8.3 millimeter Standard Deviation 16.59
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-20.3 millimeter Standard Deviation 29.20	-13.9 millimeter Standard Deviation 34.19	-20.8 millimeter Standard Deviation 30.17	-10.1 millimeter Standard Deviation 20.25
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-21.5 millimeter Standard Deviation 26.83	-13.8 millimeter Standard Deviation 36.26	-20.8 millimeter Standard Deviation 30.07	-8.8 millimeter Standard Deviation 17.57
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-23.5 millimeter Standard Deviation 26.93	-14.2 millimeter Standard Deviation 33.99	-17.3 millimeter Standard Deviation 28.80	-8.3 millimeter Standard Deviation 17.86
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-21.3 millimeter Standard Deviation 31.66	-8.2 millimeter Standard Deviation 27.93	-16.6 millimeter Standard Deviation 27.52	-7.3 millimeter Standard Deviation 17.09
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-19.9 millimeter Standard Deviation 27.82	-7.1 millimeter Standard Deviation 24.97	-19.1 millimeter Standard Deviation 31.38	-5.6 millimeter Standard Deviation 17.02
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-21.3 millimeter Standard Deviation 29.91	-6.5 millimeter Standard Deviation 21.29	-17.7 millimeter Standard Deviation 31.37	-5.5 millimeter Standard Deviation 15.59
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-22.5 millimeter Standard Deviation 26.09	-10.5 millimeter Standard Deviation 26.79	-18.9 millimeter Standard Deviation 33.97	-4.0 millimeter Standard Deviation 14.57

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Participants were evaluated on their disease activity of RA, and entered the result on the score sheet, disease activity assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Baseline	56.2 millimeter Standard Deviation 31.20	54.9 millimeter Standard Deviation 32.83	55.6 millimeter Standard Deviation 34.74	57.7 millimeter Standard Deviation 20.12	57.2 millimeter Standard Deviation 27.56	51.0 millimeter Standard Deviation 32.93	52.3 millimeter Standard Deviation 33.74	53.9 millimeter Standard Deviation 18.43
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 20	-16.7 millimeter Standard Deviation 27.33	-8.4 millimeter Standard Deviation 14.28	-12.7 millimeter Standard Deviation 26.93	-16.8 millimeter Standard Deviation 20.74	-20.9 millimeter Standard Deviation 24.16	-9.4 millimeter Standard Deviation 15.21	-12.4 millimeter Standard Deviation 28.00	-13.6 millimeter Standard Deviation 19.38
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 24	-15.9 millimeter Standard Deviation 27.17	-8.8 millimeter Standard Deviation 16.43	-16.3 millimeter Standard Deviation 27.10	-12.3 millimeter Standard Deviation 13.50	-20.0 millimeter Standard Deviation 24.13	-10.8 millimeter Standard Deviation 17.92	-16.2 millimeter Standard Deviation 28.20	-11.3 millimeter Standard Deviation 14.59
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-17.7 millimeter Standard Deviation 22.48	-13.3 millimeter Standard Deviation 26.52	-14.5 millimeter Standard Deviation 24.66	-7.7 millimeter Standard Deviation 18.61
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-22.9 millimeter Standard Deviation 27.86	-16.5 millimeter Standard Deviation 32.23	-14.5 millimeter Standard Deviation 25.67	-5.2 millimeter Standard Deviation 17.14
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-19.2 millimeter Standard Deviation 27.12	-13.7 millimeter Standard Deviation 22.84	-17.7 millimeter Standard Deviation 21.66	-11.2 millimeter Standard Deviation 25.45
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-17.4 millimeter Standard Deviation 23.95	-10.5 millimeter Standard Deviation 24.46	-14.2 millimeter Standard Deviation 24.86	-10.3 millimeter Standard Deviation 21.95
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-18.7 millimeter Standard Deviation 27.02	-17.4 millimeter Standard Deviation 31.23	-9.5 millimeter Standard Deviation 25.94	-10.9 millimeter Standard Deviation 21.74
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 2	-1.4 millimeter Standard Deviation 10.52	-4.1 millimeter Standard Deviation 13.20	-4.6 millimeter Standard Deviation 20.66	-4.7 millimeter Standard Deviation 14.21	-2.6 millimeter Standard Deviation 10.59	-4.2 millimeter Standard Deviation 14.70	-3.6 millimeter Standard Deviation 21.18	-2.7 millimeter Standard Deviation 14.71
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 4	-8.1 millimeter Standard Deviation 16.76	-12.7 millimeter Standard Deviation 25.46	-7.4 millimeter Standard Deviation 24.36	-3.9 millimeter Standard Deviation 14.72	-9.3 millimeter Standard Deviation 17.76	-11.5 millimeter Standard Deviation 25.73	-5.5 millimeter Standard Deviation 24.34	-7.0 millimeter Standard Deviation 13.75
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 8	-11.5 millimeter Standard Deviation 19.27	-13.4 millimeter Standard Deviation 29.22	-8.9 millimeter Standard Deviation 24.79	-14.8 millimeter Standard Deviation 16.50	-12.3 millimeter Standard Deviation 19.83	-11.6 millimeter Standard Deviation 32.31	-6.0 millimeter Standard Deviation 23.28	-13.4 millimeter Standard Deviation 15.37
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-22.9 millimeter Standard Deviation 27.38	-17.2 millimeter Standard Deviation 35.22	-16.5 millimeter Standard Deviation 26.51	-5.3 millimeter Standard Deviation 21.65
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-20.9 millimeter Standard Deviation 24.80	-18.3 millimeter Standard Deviation 35.75	-16.6 millimeter Standard Deviation 25.83	-4.0 millimeter Standard Deviation 19.56
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-23.5 millimeter Standard Deviation 25.13	-16.6 millimeter Standard Deviation 34.47	-13.2 millimeter Standard Deviation 23.44	-3.5 millimeter Standard Deviation 19.43
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-21.4 millimeter Standard Deviation 29.91	-11.2 millimeter Standard Deviation 27.25	-12.8 millimeter Standard Deviation 23.57	-4.7 millimeter Standard Deviation 20.23
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-20.5 millimeter Standard Deviation 26.49	-9.2 millimeter Standard Deviation 27.18	-14.1 millimeter Standard Deviation 25.89	-2.3 millimeter Standard Deviation 19.11
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-20.7 millimeter Standard Deviation 28.39	-8.2 millimeter Standard Deviation 22.01	-13.5 millimeter Standard Deviation 24.90	-0.9 millimeter Standard Deviation 17.86
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-21.9 millimeter Standard Deviation 24.06	-13.5 millimeter Standard Deviation 27.56	-14.2 millimeter Standard Deviation 27.03	0.2 millimeter Standard Deviation 16.61
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 12	-7.2 millimeter Standard Deviation 25.53	-6.9 millimeter Standard Deviation 23.69	-13.1 millimeter Standard Deviation 22.86	-13.1 millimeter Standard Deviation 20.03	-8.5 millimeter Standard Deviation 24.24	-5.8 millimeter Standard Deviation 24.73	-12.2 millimeter Standard Deviation 23.48	-13.9 millimeter Standard Deviation 18.33
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 16	-15.0 millimeter Standard Deviation 25.59	-7.4 millimeter Standard Deviation 18.94	-14.1 millimeter Standard Deviation 24.07	-13.5 millimeter Standard Deviation 17.73	-16.2 millimeter Standard Deviation 27.05	-9.5 millimeter Standard Deviation 20.91	-13.6 millimeter Standard Deviation 24.99	-13.0 millimeter Standard Deviation 18.05

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's RA disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 8	-23.8 millimeter Standard Deviation 26.32	-17.6 millimeter Standard Deviation 21.57	-19.6 millimeter Standard Deviation 27.81	-13.8 millimeter Standard Deviation 18.01	-17.7 millimeter Standard Deviation 22.40	-17.7 millimeter Standard Deviation 20.60	-20.3 millimeter Standard Deviation 28.83	-14.6 millimeter Standard Deviation 19.79
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 12	-23.3 millimeter Standard Deviation 26.50	-9.4 millimeter Standard Deviation 21.99	-19.0 millimeter Standard Deviation 30.18	-14.7 millimeter Standard Deviation 21.15	-20.5 millimeter Standard Deviation 24.71	-11.5 millimeter Standard Deviation 20.62	-20.8 millimeter Standard Deviation 30.65	-17.2 millimeter Standard Deviation 22.32
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 16	-28.4 millimeter Standard Deviation 30.15	-19.7 millimeter Standard Deviation 20.22	-23.4 millimeter Standard Deviation 29.34	-14.5 millimeter Standard Deviation 23.89	-23.6 millimeter Standard Deviation 29.57	-23.1 millimeter Standard Deviation 20.53	-24.5 millimeter Standard Deviation 30.19	-16.7 millimeter Standard Deviation 25.66
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 24	-36.7 millimeter Standard Deviation 30.38	-18.3 millimeter Standard Deviation 21.35	-17.6 millimeter Standard Deviation 26.03	-10.0 millimeter Standard Deviation 23.18	-34.8 millimeter Standard Deviation 32.06	-22.6 millimeter Standard Deviation 20.34	-18.5 millimeter Standard Deviation 26.87	-8.9 millimeter Standard Deviation 23.36
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-35.1 millimeter Standard Deviation 36.51	-25.0 millimeter Standard Deviation 24.91	-20.7 millimeter Standard Deviation 29.71	-15.6 millimeter Standard Deviation 42.85
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-35.2 millimeter Standard Deviation 38.69	-17.2 millimeter Standard Deviation 26.17	-16.3 millimeter Standard Deviation 29.29	-7.5 millimeter Standard Deviation 34.52
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-31.2 millimeter Standard Deviation 34.51	-22.9 millimeter Standard Deviation 26.79	-18.7 millimeter Standard Deviation 31.17	-6.8 millimeter Standard Deviation 33.60
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-30.4 millimeter Standard Deviation 33.71	-22.4 millimeter Standard Deviation 26.72	-22.7 millimeter Standard Deviation 31.60	-2.9 millimeter Standard Deviation 36.17
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-23.6 millimeter Standard Deviation 26.84	-23.8 millimeter Standard Deviation 30.00	-22.4 millimeter Standard Deviation 32.85	4.0 millimeter Standard Deviation 32.69
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-28.4 millimeter Standard Deviation 32.79	-14.7 millimeter Standard Deviation 28.22	-20.6 millimeter Standard Deviation 31.61	6.8 millimeter Standard Deviation 27.72
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 20	-28.9 millimeter Standard Deviation 25.67	-24.3 millimeter Standard Deviation 22.97	-20.6 millimeter Standard Deviation 27.81	-19.1 millimeter Standard Deviation 20.38	-25.9 millimeter Standard Deviation 25.94	-30.2 millimeter Standard Deviation 20.74	-21.7 millimeter Standard Deviation 28.61	-19.7 millimeter Standard Deviation 19.93
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-30.6 millimeter Standard Deviation 29.64	-20.6 millimeter Standard Deviation 22.65	-19.5 millimeter Standard Deviation 29.54	0.4 millimeter Standard Deviation 34.48
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-26.9 millimeter Standard Deviation 28.12	-24.7 millimeter Standard Deviation 26.27	-21.2 millimeter Standard Deviation 30.95	3.7 millimeter Standard Deviation 33.33
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-28.6 millimeter Standard Deviation 33.01	-23.0 millimeter Standard Deviation 28.85	-19.0 millimeter Standard Deviation 32.29	8.2 millimeter Standard Deviation 29.78
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-26.6 millimeter Standard Deviation 34.81	-20.2 millimeter Standard Deviation 26.75	-24.4 millimeter Standard Deviation 33.78	6.0 millimeter Standard Deviation 29.28
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-25.8 millimeter Standard Deviation 32.03	-19.7 millimeter Standard Deviation 30.66	-26.3 millimeter Standard Deviation 36.36	8.6 millimeter Standard Deviation 27.33
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-26.5 millimeter Standard Deviation 32.75	-19.0 millimeter Standard Deviation 31.12	-24.7 millimeter Standard Deviation 36.95	8.5 millimeter Standard Deviation 25.89
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Baseline	63.3 millimeter Standard Deviation 29.63	57.9 millimeter Standard Deviation 22.02	62.4 millimeter Standard Deviation 19.41	54.0 millimeter Standard Deviation 27.28	60.8 millimeter Standard Deviation 30.56	56.4 millimeter Standard Deviation 22.41	60.5 millimeter Standard Deviation 18.80	49.6 millimeter Standard Deviation 27.15
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 2	-16.8 millimeter Standard Deviation 16.83	-13.6 millimeter Standard Deviation 17.95	-13.3 millimeter Standard Deviation 23.08	-8.1 millimeter Standard Deviation 18.53	-15.6 millimeter Standard Deviation 17.52	-16.8 millimeter Standard Deviation 17.66	-13.9 millimeter Standard Deviation 23.89	-6.6 millimeter Standard Deviation 20.13
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 4	-20.7 millimeter Standard Deviation 13.62	-16.8 millimeter Standard Deviation 19.68	-17.8 millimeter Standard Deviation 27.46	-10.1 millimeter Standard Deviation 16.68	-18.2 millimeter Standard Deviation 12.60	-16.7 millimeter Standard Deviation 16.88	-17.7 millimeter Standard Deviation 28.58	-12.7 millimeter Standard Deviation 17.13

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Degree of disability was self-evaluated by participant using HAQ-DI.Assessment was made based on activities capable without any aids/devices.20-question instrument assessed degree of difficulty person had in accomplishing tasks in 8 functional areas(dressing,arising,eating,walking,hygiene,reaching,gripping,and activities of daily living).Responses in each functional area were scored from 0(indicated no difficulty)to 3(indicated inability to perform task in that area).Overall score computed as: sum of domain scores and divided by number of domains answered.Total possible score range:0-3 where 0=least difficulty and 3=extreme difficulty.Data for Core Treatment Phase from Week 0-10 is reported according to participant re-randomization in 4 arms at Week 12.Data reported for Extension Phase from Baseline to Week 24,is same data for Core Treatment Phase,but excluding participants who received at least 1 dose of drug and had at least 1 postdose primary efficacy measurement after Week 24-72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Baseline	0.90 units on a scale Standard Deviation 0.816	1.04 units on a scale Standard Deviation 0.770	0.88 units on a scale Standard Deviation 0.744	1.08 units on a scale Standard Deviation 0.673	0.85 units on a scale Standard Deviation 0.702	1.20 units on a scale Standard Deviation 0.789	0.76 units on a scale Standard Deviation 0.605	0.94 units on a scale Standard Deviation 0.607
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 4	0.03 units on a scale Standard Deviation 0.197	-0.25 units on a scale Standard Deviation 0.460	-0.10 units on a scale Standard Deviation 0.371	-0.03 units on a scale Standard Deviation 0.316	0.02 units on a scale Standard Deviation 0.203	-0.30 units on a scale Standard Deviation 0.485	-0.05 units on a scale Standard Deviation 0.333	-0.05 units on a scale Standard Deviation 0.334
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 12	0.12 units on a scale Standard Deviation 0.358	-0.25 units on a scale Standard Deviation 0.357	-0.06 units on a scale Standard Deviation 0.459	-0.02 units on a scale Standard Deviation 0.497	0.10 units on a scale Standard Deviation 0.369	-0.34 units on a scale Standard Deviation 0.340	-0.07 units on a scale Standard Deviation 0.478	-0.04 units on a scale Standard Deviation 0.507
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 2	0.07 units on a scale Standard Deviation 0.163	-0.03 units on a scale Standard Deviation 0.399	-0.08 units on a scale Standard Deviation 0.297	0.01 units on a scale Standard Deviation 0.258	0.07 units on a scale Standard Deviation 0.174	-0.08 units on a scale Standard Deviation 0.423	-0.04 units on a scale Standard Deviation 0.262	0.00 units on a scale Standard Deviation 0.270
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 8	-0.04 units on a scale Standard Deviation 0.181	-0.38 units on a scale Standard Deviation 0.595	-0.10 units on a scale Standard Deviation 0.344	-0.05 units on a scale Standard Deviation 0.404	-0.07 units on a scale Standard Deviation 0.174	-0.47 units on a scale Standard Deviation 0.647	-0.09 units on a scale Standard Deviation 0.355	-0.10 units on a scale Standard Deviation 0.428
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 16	0.03 units on a scale Standard Deviation 0.376	-0.11 units on a scale Standard Deviation 0.395	-0.11 units on a scale Standard Deviation 0.495	-0.04 units on a scale Standard Deviation 0.421	0.02 units on a scale Standard Deviation 0.405	-0.22 units on a scale Standard Deviation 0.354	-0.13 units on a scale Standard Deviation 0.510	-0.04 units on a scale Standard Deviation 0.457
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 20	-0.04 units on a scale Standard Deviation 0.400	-0.21 units on a scale Standard Deviation 0.341	-0.15 units on a scale Standard Deviation 0.619	-0.02 units on a scale Standard Deviation 0.579	-0.07 units on a scale Standard Deviation 0.426	-0.30 units on a scale Standard Deviation 0.341	-0.19 units on a scale Standard Deviation 0.624	0.04 units on a scale Standard Deviation 0.604
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 24	-0.04 units on a scale Standard Deviation 0.483	-0.23 units on a scale Standard Deviation 0.395	-0.23 units on a scale Standard Deviation 0.574	0.02 units on a scale Standard Deviation 0.464	-0.07 units on a scale Standard Deviation 0.517	-0.33 units on a scale Standard Deviation 0.388	-0.28 units on a scale Standard Deviation 0.569	0.04 units on a scale Standard Deviation 0.510
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-0.10 units on a scale Standard Deviation 0.521	-0.31 units on a scale Standard Deviation 0.401	-0.25 units on a scale Standard Deviation 0.448	0.23 units on a scale Standard Deviation 0.770
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-0.09 units on a scale Standard Deviation 0.596	-0.26 units on a scale Standard Deviation 0.469	-0.13 units on a scale Standard Deviation 0.518	0.06 units on a scale Standard Deviation 0.461
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-0.13 units on a scale Standard Deviation 0.545	-0.23 units on a scale Standard Deviation 0.467	-0.18 units on a scale Standard Deviation 0.450	0.19 units on a scale Standard Deviation 0.409
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-0.04 units on a scale Standard Deviation 0.620	-0.26 units on a scale Standard Deviation 0.495	-0.16 units on a scale Standard Deviation 0.458	0.18 units on a scale Standard Deviation 0.457
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-0.10 units on a scale Standard Deviation 0.557	-0.24 units on a scale Standard Deviation 0.514	-0.18 units on a scale Standard Deviation 0.441	0.26 units on a scale Standard Deviation 0.488
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-0.13 units on a scale Standard Deviation 0.534	-0.31 units on a scale Standard Deviation 0.566	-0.18 units on a scale Standard Deviation 0.464	0.23 units on a scale Standard Deviation 0.432
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-0.14 units on a scale Standard Deviation 0.588	-0.25 units on a scale Standard Deviation 0.565	-0.21 units on a scale Standard Deviation 0.443	0.24 units on a scale Standard Deviation 0.370
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-0.14 units on a scale Standard Deviation 0.629	-0.25 units on a scale Standard Deviation 0.565	-0.19 units on a scale Standard Deviation 0.429	0.28 units on a scale Standard Deviation 0.362
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-0.13 units on a scale Standard Deviation 0.664	-0.20 units on a scale Standard Deviation 0.522	-0.12 units on a scale Standard Deviation 0.452	0.24 units on a scale Standard Deviation 0.370
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-0.14 units on a scale Standard Deviation 0.682	-0.18 units on a scale Standard Deviation 0.534	-0.16 units on a scale Standard Deviation 0.496	0.28 units on a scale Standard Deviation 0.471
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-0.13 units on a scale Standard Deviation 0.672	-0.22 units on a scale Standard Deviation 0.542	-0.17 units on a scale Standard Deviation 0.480	0.25 units on a scale Standard Deviation 0.391
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-0.17 units on a scale Standard Deviation 0.632	-0.20 units on a scale Standard Deviation 0.540	-0.15 units on a scale Standard Deviation 0.575	0.24 units on a scale Standard Deviation 0.473

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

CRP of each participants was measured as a part of blood biochemical tests. A normal CRP value is less than (\<) 10 milligram per deciliter (mg/dL). A test result showing a CRP level greater than 10 mg/dL is a sign of chronic disease. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	0.83 mg/dL Standard Deviation 1.801	0.25 mg/dL Standard Deviation 1.642	-1.16 mg/dL Standard Deviation 3.002	0.72 mg/dL Standard Deviation 1.430
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 2	0.47 mg/dL Standard Deviation 0.795	0.02 mg/dL Standard Deviation 1.701	-0.39 mg/dL Standard Deviation 1.438	-0.13 mg/dL Standard Deviation 0.870	0.46 mg/dL Standard Deviation 0.855	0.23 mg/dL Standard Deviation 1.782	-0.45 mg/dL Standard Deviation 1.473	-0.11 mg/dL Standard Deviation 0.277
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	1.08 mg/dL Standard Deviation 1.857	0.38 mg/dL Standard Deviation 1.459	-0.50 mg/dL Standard Deviation 3.730	0.86 mg/dL Standard Deviation 1.559
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	0.83 mg/dL Standard Deviation 1.791	0.29 mg/dL Standard Deviation 1.592	-0.94 mg/dL Standard Deviation 3.036	0.97 mg/dL Standard Deviation 1.686
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 20	0.19 mg/dL Standard Deviation 1.278	-0.41 mg/dL Standard Deviation 1.792	0.49 mg/dL Standard Deviation 2.713	0.56 mg/dL Standard Deviation 2.257	0.36 mg/dL Standard Deviation 1.180	-0.10 mg/dL Standard Deviation 0.849	0.35 mg/dL Standard Deviation 2.771	0.37 mg/dL Standard Deviation 0.660
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 24	0.21 mg/dL Standard Deviation 1.144	-0.31 mg/dL Standard Deviation 1.692	-0.49 mg/dL Standard Deviation 2.893	0.47 mg/dL Standard Deviation 2.047	0.38 mg/dL Standard Deviation 1.004	0.15 mg/dL Standard Deviation 0.652	-0.71 mg/dL Standard Deviation 2.892	0.65 mg/dL Standard Deviation 1.682
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	0.42 mg/dL Standard Deviation 1.023	0.02 mg/dL Standard Deviation 1.301	-0.65 mg/dL Standard Deviation 3.002	0.75 mg/dL Standard Deviation 1.678
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	0.48 mg/dL Standard Deviation 1.250	0.09 mg/dL Standard Deviation 1.818	-1.12 mg/dL Standard Deviation 2.881	0.69 mg/dL Standard Deviation 1.610
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	0.81 mg/dL Standard Deviation 1.834	0.10 mg/dL Standard Deviation 1.625	-1.16 mg/dL Standard Deviation 2.638	0.67 mg/dL Standard Deviation 1.516
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	0.75 mg/dL Standard Deviation 1.825	0.25 mg/dL Standard Deviation 1.490	-0.42 mg/dL Standard Deviation 1.840	1.01 mg/dL Standard Deviation 2.006
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Baseline	1.08 mg/dL Standard Deviation 1.299	2.50 mg/dL Standard Deviation 4.012	3.09 mg/dL Standard Deviation 3.186	1.68 mg/dL Standard Deviation 2.504	0.94 mg/dL Standard Deviation 1.097	1.83 mg/dL Standard Deviation 2.893	3.10 mg/dL Standard Deviation 3.316	0.81 mg/dL Standard Deviation 0.736
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 4	0.18 mg/dL Standard Deviation 0.507	-0.63 mg/dL Standard Deviation 2.308	-0.25 mg/dL Standard Deviation 0.938	0.73 mg/dL Standard Deviation 3.043	0.23 mg/dL Standard Deviation 0.525	-0.01 mg/dL Standard Deviation 0.636	-0.30 mg/dL Standard Deviation 0.957	-0.02 mg/dL Standard Deviation 0.239
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 8	-0.06 mg/dL Standard Deviation 0.579	-0.33 mg/dL Standard Deviation 2.229	-0.09 mg/dL Standard Deviation 1.277	0.43 mg/dL Standard Deviation 1.644	0.05 mg/dL Standard Deviation 0.389	0.30 mg/dL Standard Deviation 0.518	-0.20 mg/dL Standard Deviation 1.262	0.07 mg/dL Standard Deviation 0.680
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 12	0.15 mg/dL Standard Deviation 0.978	-0.44 mg/dL Standard Deviation 1.643	0.07 mg/dL Standard Deviation 2.524	0.40 mg/dL Standard Deviation 1.618	0.32 mg/dL Standard Deviation 0.814	-0.18 mg/dL Standard Deviation 0.810	0.02 mg/dL Standard Deviation 2.618	0.33 mg/dL Standard Deviation 1.048
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 16	0.05 mg/dL Standard Deviation 1.090	-0.42 mg/dL Standard Deviation 1.755	0.08 mg/dL Standard Deviation 1.943	0.63 mg/dL Standard Deviation 2.343	0.22 mg/dL Standard Deviation 0.965	-0.10 mg/dL Standard Deviation 0.835	-0.09 mg/dL Standard Deviation 1.909	0.28 mg/dL Standard Deviation 0.870
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	0.99 mg/dL Standard Deviation 1.783	0.21 mg/dL Standard Deviation 1.653	-1.04 mg/dL Standard Deviation 2.757	0.98 mg/dL Standard Deviation 1.764
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	0.90 mg/dL Standard Deviation 1.859	0.63 mg/dL Standard Deviation 1.521	-1.04 mg/dL Standard Deviation 3.060	0.67 mg/dL Standard Deviation 1.399
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	0.80 mg/dL Standard Deviation 1.828	0.58 mg/dL Standard Deviation 1.405	-1.04 mg/dL Standard Deviation 3.168	0.69 mg/dL Standard Deviation 1.376
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	0.76 mg/dL Standard Deviation 1.803	0.47 mg/dL Standard Deviation 1.465	-0.87 mg/dL Standard Deviation 2.213	0.77 mg/dL Standard Deviation 1.512
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	1.10 mg/dL Standard Deviation 1.914	0.40 mg/dL Standard Deviation 1.641	-1.10 mg/dL Standard Deviation 2.565	0.67 mg/dL Standard Deviation 1.462

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 4	8.6 millimeter per hour (mm/hr) Standard Deviation 14.66	2.1 millimeter per hour (mm/hr) Standard Deviation 18.56	-0.3 millimeter per hour (mm/hr) Standard Deviation 11.56	1.4 millimeter per hour (mm/hr) Standard Deviation 15.41	9.5 millimeter per hour (mm/hr) Standard Deviation 15.59	1.5 millimeter per hour (mm/hr) Standard Deviation 16.66	-0.9 millimeter per hour (mm/hr) Standard Deviation 11.77	-4.0 millimeter per hour (mm/hr) Standard Deviation 9.59
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 12	1.8 millimeter per hour (mm/hr) Standard Deviation 10.14	5.1 millimeter per hour (mm/hr) Standard Deviation 23.65	-1.5 millimeter per hour (mm/hr) Standard Deviation 22.06	6.8 millimeter per hour (mm/hr) Standard Deviation 19.60	2.1 millimeter per hour (mm/hr) Standard Deviation 10.80	4.7 millimeter per hour (mm/hr) Standard Deviation 21.64	-3.8 millimeter per hour (mm/hr) Standard Deviation 21.06	4.5 millimeter per hour (mm/hr) Standard Deviation 20.74
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Baseline	33.1 millimeter per hour (mm/hr) Standard Deviation 19.55	44.4 millimeter per hour (mm/hr) Standard Deviation 25.70	51.8 millimeter per hour (mm/hr) Standard Deviation 34.26	35.3 millimeter per hour (mm/hr) Standard Deviation 18.44	33.9 millimeter per hour (mm/hr) Standard Deviation 19.56	41.2 millimeter per hour (mm/hr) Standard Deviation 25.81	49.9 millimeter per hour (mm/hr) Standard Deviation 34.91	32.3 millimeter per hour (mm/hr) Standard Deviation 18.89
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 2	8.1 millimeter per hour (mm/hr) Standard Deviation 14.36	0.2 millimeter per hour (mm/hr) Standard Deviation 12.43	1.5 millimeter per hour (mm/hr) Standard Deviation 11.63	1.5 millimeter per hour (mm/hr) Standard Deviation 10.28	8.6 millimeter per hour (mm/hr) Standard Deviation 15.37	-1.2 millimeter per hour (mm/hr) Standard Deviation 13.39	-0.8 millimeter per hour (mm/hr) Standard Deviation 8.28	-1.9 millimeter per hour (mm/hr) Standard Deviation 6.54
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 8	4.2 millimeter per hour (mm/hr) Standard Deviation 9.53	5.4 millimeter per hour (mm/hr) Standard Deviation 15.78	-0.5 millimeter per hour (mm/hr) Standard Deviation 17.72	3.9 millimeter per hour (mm/hr) Standard Deviation 21.68	4.6 millimeter per hour (mm/hr) Standard Deviation 10.21	3.5 millimeter per hour (mm/hr) Standard Deviation 14.36	-2.3 millimeter per hour (mm/hr) Standard Deviation 17.05	-2.6 millimeter per hour (mm/hr) Standard Deviation 16.87
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 16	4.7 millimeter per hour (mm/hr) Standard Deviation 10.64	-3.4 millimeter per hour (mm/hr) Standard Deviation 14.11	-3.0 millimeter per hour (mm/hr) Standard Deviation 23.33	3.0 millimeter per hour (mm/hr) Standard Deviation 23.46	5.8 millimeter per hour (mm/hr) Standard Deviation 10.90	-3.4 millimeter per hour (mm/hr) Standard Deviation 15.64	-3.5 millimeter per hour (mm/hr) Standard Deviation 24.22	0.8 millimeter per hour (mm/hr) Standard Deviation 23.29
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 20	2.3 millimeter per hour (mm/hr) Standard Deviation 12.72	-0.4 millimeter per hour (mm/hr) Standard Deviation 11.04	1.2 millimeter per hour (mm/hr) Standard Deviation 31.07	6.9 millimeter per hour (mm/hr) Standard Deviation 18.59	2.8 millimeter per hour (mm/hr) Standard Deviation 13.45	0.6 millimeter per hour (mm/hr) Standard Deviation 11.96	-0.8 millimeter per hour (mm/hr) Standard Deviation 31.33	2.7 millimeter per hour (mm/hr) Standard Deviation 16.91
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 24	8.2 millimeter per hour (mm/hr) Standard Deviation 17.51	-2.7 millimeter per hour (mm/hr) Standard Deviation 14.74	-0.1 millimeter per hour (mm/hr) Standard Deviation 33.28	9.3 millimeter per hour (mm/hr) Standard Deviation 19.00	9.6 millimeter per hour (mm/hr) Standard Deviation 18.32	-2.4 millimeter per hour (mm/hr) Standard Deviation 16.48	-2.3 millimeter per hour (mm/hr) Standard Deviation 33.60	4.5 millimeter per hour (mm/hr) Standard Deviation 15.46
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	6.5 millimeter per hour (mm/hr) Standard Deviation 18.39	-6.1 millimeter per hour (mm/hr) Standard Deviation 13.12	-5.2 millimeter per hour (mm/hr) Standard Deviation 35.53	2.3 millimeter per hour (mm/hr) Standard Deviation 21.19
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	10.1 millimeter per hour (mm/hr) Standard Deviation 19.73	-2.5 millimeter per hour (mm/hr) Standard Deviation 19.24	-7.4 millimeter per hour (mm/hr) Standard Deviation 39.76	-0.8 millimeter per hour (mm/hr) Standard Deviation 23.88
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	10.6 millimeter per hour (mm/hr) Standard Deviation 19.70	-1.4 millimeter per hour (mm/hr) Standard Deviation 20.41	-4.1 millimeter per hour (mm/hr) Standard Deviation 30.55	-0.3 millimeter per hour (mm/hr) Standard Deviation 25.25
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	12.2 millimeter per hour (mm/hr) Standard Deviation 18.88	-3.8 millimeter per hour (mm/hr) Standard Deviation 16.78	-3.4 millimeter per hour (mm/hr) Standard Deviation 19.89	3.0 millimeter per hour (mm/hr) Standard Deviation 31.65
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	12.2 millimeter per hour (mm/hr) Standard Deviation 18.67	0.8 millimeter per hour (mm/hr) Standard Deviation 17.87	-4.8 millimeter per hour (mm/hr) Standard Deviation 21.23	8.1 millimeter per hour (mm/hr) Standard Deviation 26.33
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	11.8 millimeter per hour (mm/hr) Standard Deviation 18.90	-2.5 millimeter per hour (mm/hr) Standard Deviation 18.18	-6.0 millimeter per hour (mm/hr) Standard Deviation 25.17	5.7 millimeter per hour (mm/hr) Standard Deviation 32.19
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	16.1 millimeter per hour (mm/hr) Standard Deviation 17.46	-1.3 millimeter per hour (mm/hr) Standard Deviation 18.77	-5.6 millimeter per hour (mm/hr) Standard Deviation 26.41	0.9 millimeter per hour (mm/hr) Standard Deviation 22.43
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	14.8 millimeter per hour (mm/hr) Standard Deviation 20.93	1.4 millimeter per hour (mm/hr) Standard Deviation 18.92	-6.3 millimeter per hour (mm/hr) Standard Deviation 28.79	1.2 millimeter per hour (mm/hr) Standard Deviation 26.16
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	15.2 millimeter per hour (mm/hr) Standard Deviation 18.43	3.5 millimeter per hour (mm/hr) Standard Deviation 19.91	-5.7 millimeter per hour (mm/hr) Standard Deviation 28.67	3.7 millimeter per hour (mm/hr) Standard Deviation 25.95
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	15.3 millimeter per hour (mm/hr) Standard Deviation 17.84	1.0 millimeter per hour (mm/hr) Standard Deviation 17.38	-3.5 millimeter per hour (mm/hr) Standard Deviation 21.04	3.0 millimeter per hour (mm/hr) Standard Deviation 26.24
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	16.5 millimeter per hour (mm/hr) Standard Deviation 17.88	1.6 millimeter per hour (mm/hr) Standard Deviation 20.10	-4.6 millimeter per hour (mm/hr) Standard Deviation 23.94	2.8 millimeter per hour (mm/hr) Standard Deviation 25.88
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	16.5 millimeter per hour (mm/hr) Standard Deviation 18.00	3.1 millimeter per hour (mm/hr) Standard Deviation 20.22	-4.4 millimeter per hour (mm/hr) Standard Deviation 26.88	7.1 millimeter per hour (mm/hr) Standard Deviation 28.04

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above=high disease activity, a value greater than (\>) 3.2 and less than or equal to (\<=) 5.1=moderate disease activity and value \<=3.2=low disease activity, value \<2.6=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 16	-0.915 score on a scale Standard Deviation 1.3442	-1.005 score on a scale Standard Deviation 0.9633	-0.686 score on a scale Standard Deviation 1.2377	-1.431 score on a scale Standard Deviation 0.9735	-0.910 score on a scale Standard Deviation 1.4311	-1.148 score on a scale Standard Deviation 1.0416	-0.664 score on a scale Standard Deviation 1.2855	-1.475 score on a scale Standard Deviation 0.9937
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 20	-1.052 score on a scale Standard Deviation 1.2322	-0.983 score on a scale Standard Deviation 1.0665	-0.593 score on a scale Standard Deviation 1.4253	-1.459 score on a scale Standard Deviation 1.1873	-1.119 score on a scale Standard Deviation 1.3126	-1.114 score on a scale Standard Deviation 1.1754	-0.622 score on a scale Standard Deviation 1.4794	-1.316 score on a scale Standard Deviation 1.0018
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 24	-1.144 score on a scale Standard Deviation 1.3770	-0.880 score on a scale Standard Deviation 1.5753	-0.621 score on a scale Standard Deviation 1.4654	-1.237 score on a scale Standard Deviation 1.2485	-1.226 score on a scale Standard Deviation 1.4651	-0.996 score on a scale Standard Deviation 1.7744	-0.651 score on a scale Standard Deviation 1.5206	-1.250 score on a scale Standard Deviation 1.3487
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-1.021 score on a scale Standard Deviation 1.5467	-1.400 score on a scale Standard Deviation 1.8959	-0.717 score on a scale Standard Deviation 1.5407	-1.265 score on a scale Standard Deviation 1.5622
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-0.755 score on a scale Standard Deviation 1.5599	-1.015 score on a scale Standard Deviation 1.7114	-0.973 score on a scale Standard Deviation 2.0715	-1.283 score on a scale Standard Deviation 1.5960
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-0.900 score on a scale Standard Deviation 1.6899	-1.156 score on a scale Standard Deviation 2.0018	-0.895 score on a scale Standard Deviation 1.7231	-0.736 score on a scale Standard Deviation 1.5585
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-0.779 score on a scale Standard Deviation 1.5890	-1.262 score on a scale Standard Deviation 2.2876	-0.889 score on a scale Standard Deviation 1.8339	-0.967 score on a scale Standard Deviation 1.5410
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-0.634 score on a scale Standard Deviation 1.4797	-0.804 score on a scale Standard Deviation 1.4963	-1.119 score on a scale Standard Deviation 2.0381	-0.991 score on a scale Standard Deviation 1.5604
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-0.544 score on a scale Standard Deviation 1.4247	-0.683 score on a scale Standard Deviation 1.4337	-1.182 score on a scale Standard Deviation 2.0758	-0.925 score on a scale Standard Deviation 1.6162
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-0.849 score on a scale Standard Deviation 1.5612	-1.316 score on a scale Standard Deviation 2.1913	-0.881 score on a scale Standard Deviation 1.7674	-0.697 score on a scale Standard Deviation 1.4635
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-0.552 score on a scale Standard Deviation 1.3993	-1.283 score on a scale Standard Deviation 2.3802	-1.026 score on a scale Standard Deviation 1.8598	-1.146 score on a scale Standard Deviation 1.5067
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-0.653 score on a scale Standard Deviation 1.4101	-0.854 score on a scale Standard Deviation 1.6351	-0.908 score on a scale Standard Deviation 2.1318	-0.830 score on a scale Standard Deviation 1.5182
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-0.654 score on a scale Standard Deviation 1.4252	-1.076 score on a scale Standard Deviation 1.8640	-1.169 score on a scale Standard Deviation 2.1891	-0.684 score on a scale Standard Deviation 1.4746
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Baseline	5.479 score on a scale Standard Deviation 1.2520	5.870 score on a scale Standard Deviation 1.3037	5.951 score on a scale Standard Deviation 1.1584	5.971 score on a scale Standard Deviation 0.9561	5.460 score on a scale Standard Deviation 0.9793	5.696 score on a scale Standard Deviation 1.3749	5.849 score on a scale Standard Deviation 1.1389	5.623 score on a scale Standard Deviation 0.5133
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 2	-0.212 score on a scale Standard Deviation 0.5989	-0.340 score on a scale Standard Deviation 0.5440	-0.401 score on a scale Standard Deviation 0.7715	-0.658 score on a scale Standard Deviation 0.4838	-0.262 score on a scale Standard Deviation 0.6308	-0.363 score on a scale Standard Deviation 0.6115	-0.426 score on a scale Standard Deviation 0.7970	-0.593 score on a scale Standard Deviation 0.5036
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 4	-0.546 score on a scale Standard Deviation 1.1731	-0.674 score on a scale Standard Deviation 1.0013	-0.489 score on a scale Standard Deviation 1.0301	-0.870 score on a scale Standard Deviation 0.7421	-0.582 score on a scale Standard Deviation 1.2502	-0.697 score on a scale Standard Deviation 1.0573	-0.446 score on a scale Standard Deviation 1.0589	-0.971 score on a scale Standard Deviation 0.7646
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 8	-0.719 score on a scale Standard Deviation 0.9115	-0.797 score on a scale Standard Deviation 1.7366	-0.452 score on a scale Standard Deviation 1.0405	-1.098 score on a scale Standard Deviation 0.6243	-0.739 score on a scale Standard Deviation 0.9760	-0.928 score on a scale Standard Deviation 1.9411	-0.390 score on a scale Standard Deviation 1.0558	-1.199 score on a scale Standard Deviation 0.6263
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 12	-0.633 score on a scale Standard Deviation 1.1583	-0.532 score on a scale Standard Deviation 1.4324	-0.710 score on a scale Standard Deviation 1.2693	-1.012 score on a scale Standard Deviation 0.8396	-0.749 score on a scale Standard Deviation 1.1879	-0.654 score on a scale Standard Deviation 1.5342	-0.727 score on a scale Standard Deviation 1.3193	-1.121 score on a scale Standard Deviation 0.8512
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-1.009 score on a scale Standard Deviation 1.6211	-1.136 score on a scale Standard Deviation 1.9269	-0.733 score on a scale Standard Deviation 1.6623	-1.210 score on a scale Standard Deviation 1.7566
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-0.790 score on a scale Standard Deviation 1.5655	-1.167 score on a scale Standard Deviation 1.8142	-0.954 score on a scale Standard Deviation 1.7462	-0.976 score on a scale Standard Deviation 1.6523

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 4.1 or above=high disease activity, a value \>2.7 and \<=4.1=moderate disease activity and a value \<=2.7=low disease activity, value \<2.3=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 4	-0.672 score on a scale Standard Deviation 1.0587	-0.653 score on a scale Standard Deviation 0.7404	-0.550 score on a scale Standard Deviation 1.0307	-0.808 score on a scale Standard Deviation 0.6209	-0.719 score on a scale Standard Deviation 1.1249	-0.607 score on a scale Standard Deviation 0.7575	-0.510 score on a scale Standard Deviation 1.0611	-0.881 score on a scale Standard Deviation 0.6595
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-0.864 score on a scale Standard Deviation 1.4813	-0.846 score on a scale Standard Deviation 1.4961	-1.012 score on a scale Standard Deviation 1.7898	-1.224 score on a scale Standard Deviation 1.4763
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-0.817 score on a scale Standard Deviation 1.3728	-1.232 score on a scale Standard Deviation 1.8140	-0.877 score on a scale Standard Deviation 1.6018	-0.914 score on a scale Standard Deviation 1.3941
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-0.713 score on a scale Standard Deviation 1.3495	-0.688 score on a scale Standard Deviation 1.1425	-1.184 score on a scale Standard Deviation 1.8181	-0.890 score on a scale Standard Deviation 1.4800
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Baseline	4.842 score on a scale Standard Deviation 1.2628	5.194 score on a scale Standard Deviation 1.2869	5.305 score on a scale Standard Deviation 1.1055	5.318 score on a scale Standard Deviation 1.0756	4.780 score on a scale Standard Deviation 0.9932	5.033 score on a scale Standard Deviation 1.3186	5.218 score on a scale Standard Deviation 1.0996	4.909 score on a scale Standard Deviation 0.5330
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 2	-0.277 score on a scale Standard Deviation 0.5794	-0.313 score on a scale Standard Deviation 0.4086	-0.459 score on a scale Standard Deviation 0.7658	-0.691 score on a scale Standard Deviation 0.5431	-0.353 score on a scale Standard Deviation 0.5823	-0.314 score on a scale Standard Deviation 0.4634	-0.475 score on a scale Standard Deviation 0.7948	-0.596 score on a scale Standard Deviation 0.5478
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 8	-0.790 score on a scale Standard Deviation 0.8574	-0.806 score on a scale Standard Deviation 1.4652	-0.448 score on a scale Standard Deviation 1.0170	-1.108 score on a scale Standard Deviation 0.5967	-0.802 score on a scale Standard Deviation 0.9214	-0.864 score on a scale Standard Deviation 1.6578	-0.381 score on a scale Standard Deviation 1.0262	-1.167 score on a scale Standard Deviation 0.6389
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 12	-0.567 score on a scale Standard Deviation 1.0958	-0.559 score on a scale Standard Deviation 1.2972	-0.704 score on a scale Standard Deviation 1.1604	-1.095 score on a scale Standard Deviation 0.8393	-0.657 score on a scale Standard Deviation 1.1280	-0.680 score on a scale Standard Deviation 1.3724	-0.710 score on a scale Standard Deviation 1.2076	-1.196 score on a scale Standard Deviation 0.8728
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 16	-1.032 score on a scale Standard Deviation 1.3230	-0.807 score on a scale Standard Deviation 0.7085	-0.662 score on a scale Standard Deviation 1.1490	-1.448 score on a scale Standard Deviation 1.0766	-1.020 score on a scale Standard Deviation 1.4086	-0.923 score on a scale Standard Deviation 0.7435	-0.652 score on a scale Standard Deviation 1.1953	-1.501 score on a scale Standard Deviation 1.1190
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 20	-1.086 score on a scale Standard Deviation 1.2175	-0.913 score on a scale Standard Deviation 0.9640	-0.569 score on a scale Standard Deviation 1.2364	-1.501 score on a scale Standard Deviation 1.1683	-1.152 score on a scale Standard Deviation 1.3004	-1.054 score on a scale Standard Deviation 1.0421	-0.595 score on a scale Standard Deviation 1.2832	-1.329 score on a scale Standard Deviation 1.0122
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 24	-1.226 score on a scale Standard Deviation 1.2308	-0.744 score on a scale Standard Deviation 1.3057	-0.664 score on a scale Standard Deviation 1.3388	-1.312 score on a scale Standard Deviation 1.2535	-1.313 score on a scale Standard Deviation 1.3047	-0.821 score on a scale Standard Deviation 1.4747	-0.696 score on a scale Standard Deviation 1.3878	-1.275 score on a scale Standard Deviation 1.3575
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-1.080 score on a scale Standard Deviation 1.4327	-1.159 score on a scale Standard Deviation 1.5168	-0.753 score on a scale Standard Deviation 1.3526	-1.265 score on a scale Standard Deviation 1.5105
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-1.045 score on a scale Standard Deviation 1.4527	-1.209 score on a scale Standard Deviation 1.4589	-0.801 score on a scale Standard Deviation 1.5149	-1.120 score on a scale Standard Deviation 1.5781
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-0.883 score on a scale Standard Deviation 1.4812	-1.093 score on a scale Standard Deviation 1.3147	-0.965 score on a scale Standard Deviation 1.5133	-0.886 score on a scale Standard Deviation 1.4063
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-0.939 score on a scale Standard Deviation 1.6417	-1.198 score on a scale Standard Deviation 1.5077	-0.934 score on a scale Standard Deviation 1.5769	-0.761 score on a scale Standard Deviation 1.5076
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-0.878 score on a scale Standard Deviation 1.4321	-1.267 score on a scale Standard Deviation 1.7114	-0.866 score on a scale Standard Deviation 1.5055	-0.653 score on a scale Standard Deviation 1.2861
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-0.688 score on a scale Standard Deviation 1.2532	-1.248 score on a scale Standard Deviation 1.8622	-1.023 score on a scale Standard Deviation 1.6672	-1.057 score on a scale Standard Deviation 1.3742
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-0.787 score on a scale Standard Deviation 1.3827	-0.794 score on a scale Standard Deviation 1.1386	-1.070 score on a scale Standard Deviation 1.7630	-0.948 score on a scale Standard Deviation 1.4326
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-0.779 score on a scale Standard Deviation 1.2602	-0.850 score on a scale Standard Deviation 1.2527	-0.871 score on a scale Standard Deviation 1.8144	-0.818 score on a scale Standard Deviation 1.4112
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-0.836 score on a scale Standard Deviation 1.2718	-1.152 score on a scale Standard Deviation 1.5226	-1.156 score on a scale Standard Deviation 1.9211	-0.682 score on a scale Standard Deviation 1.3581

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 26 or above=high disease activity, a value \>11 and \<=26=moderate disease activity and value \<=11=low disease activity, value \<=3.3=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 12	-6.793 score on a scale Standard Deviation 10.2078	-8.421 score on a scale Standard Deviation 17.5072	-7.643 score on a scale Standard Deviation 14.2285	-12.792 score on a scale Standard Deviation 8.4873	-9.023 score on a scale Standard Deviation 12.2819	-9.827 score on a scale Standard Deviation 18.8785	-7.815 score on a scale Standard Deviation 14.7942	-13.080 score on a scale Standard Deviation 9.0454
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 16	-11.760 score on a scale Standard Deviation 13.4649	-12.700 score on a scale Standard Deviation 11.1552	-8.521 score on a scale Standard Deviation 14.8650	-14.917 score on a scale Standard Deviation 10.6017	-11.762 score on a scale Standard Deviation 14.5004	-13.809 score on a scale Standard Deviation 12.3841	-8.446 score on a scale Standard Deviation 15.4692	-14.290 score on a scale Standard Deviation 10.4209
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 24	-14.107 score on a scale Standard Deviation 13.4448	-12.086 score on a scale Standard Deviation 16.8719	-7.171 score on a scale Standard Deviation 16.5184	-13.517 score on a scale Standard Deviation 12.9978	-14.946 score on a scale Standard Deviation 14.3229	-13.109 score on a scale Standard Deviation 19.0562	-7.569 score on a scale Standard Deviation 17.1230	-11.670 score on a scale Standard Deviation 12.9570
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-12.569 score on a scale Standard Deviation 15.7788	-14.655 score on a scale Standard Deviation 19.3982	-8.600 score on a scale Standard Deviation 19.1369	-9.300 score on a scale Standard Deviation 17.4237
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-11.438 score on a scale Standard Deviation 15.7793	-13.945 score on a scale Standard Deviation 18.4699	-10.215 score on a scale Standard Deviation 17.5279	-7.950 score on a scale Standard Deviation 17.2220
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Baseline	29.767 score on a scale Standard Deviation 13.8824	34.986 score on a scale Standard Deviation 16.9418	33.750 score on a scale Standard Deviation 11.5847	34.508 score on a scale Standard Deviation 14.2748	28.431 score on a scale Standard Deviation 11.1731	33.745 score on a scale Standard Deviation 17.7674	33.069 score on a scale Standard Deviation 11.7626	29.060 score on a scale Standard Deviation 6.6750
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 2	-5.620 score on a scale Standard Deviation 7.5960	-5.607 score on a scale Standard Deviation 7.1229	-6.100 score on a scale Standard Deviation 9.3523	-9.075 score on a scale Standard Deviation 8.0323	-6.054 score on a scale Standard Deviation 8.1006	-5.873 score on a scale Standard Deviation 8.0467	-6.362 score on a scale Standard Deviation 9.6807	-6.640 score on a scale Standard Deviation 6.2285
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 4	-7.767 score on a scale Standard Deviation 9.6279	-10.221 score on a scale Standard Deviation 11.8874	-6.836 score on a scale Standard Deviation 12.3932	-9.667 score on a scale Standard Deviation 5.8116	-8.062 score on a scale Standard Deviation 10.2120	-9.382 score on a scale Standard Deviation 11.9577	-6.392 score on a scale Standard Deviation 12.7832	-9.790 score on a scale Standard Deviation 6.4160
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 8	-10.260 score on a scale Standard Deviation 8.9168	-11.136 score on a scale Standard Deviation 18.0780	-5.586 score on a scale Standard Deviation 13.8352	-13.008 score on a scale Standard Deviation 5.7949	-10.023 score on a scale Standard Deviation 9.5951	-11.545 score on a scale Standard Deviation 20.3240	-4.985 score on a scale Standard Deviation 14.2086	-12.930 score on a scale Standard Deviation 6.3990
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 20	-12.167 score on a scale Standard Deviation 14.0241	-13.536 score on a scale Standard Deviation 13.7755	-6.907 score on a scale Standard Deviation 15.9803	-17.033 score on a scale Standard Deviation 11.3561	-12.708 score on a scale Standard Deviation 15.0684	-14.964 score on a scale Standard Deviation 15.3173	-7.285 score on a scale Standard Deviation 16.5677	-14.760 score on a scale Standard Deviation 8.8873
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-13.708 score on a scale Standard Deviation 15.3680	-13.945 score on a scale Standard Deviation 20.3219	-7.954 score on a scale Standard Deviation 17.7855	-11.230 score on a scale Standard Deviation 13.3073
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-12.169 score on a scale Standard Deviation 15.7365	-11.855 score on a scale Standard Deviation 18.5106	-8.708 score on a scale Standard Deviation 19.9022	-10.890 score on a scale Standard Deviation 14.0719
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-11.277 score on a scale Standard Deviation 17.4198	-14.509 score on a scale Standard Deviation 19.4841	-9.285 score on a scale Standard Deviation 19.7611	-6.820 score on a scale Standard Deviation 16.7918
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-11.685 score on a scale Standard Deviation 15.4954	-15.073 score on a scale Standard Deviation 20.5706	-9.731 score on a scale Standard Deviation 19.3009	-5.180 score on a scale Standard Deviation 14.7420
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-8.469 score on a scale Standard Deviation 13.4793	-14.682 score on a scale Standard Deviation 22.2529	-10.369 score on a scale Standard Deviation 20.2755	-8.480 score on a scale Standard Deviation 15.8229
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-9.577 score on a scale Standard Deviation 14.5219	-14.700 score on a scale Standard Deviation 21.6976	-9.177 score on a scale Standard Deviation 19.7402	-7.060 score on a scale Standard Deviation 15.2876
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-9.269 score on a scale Standard Deviation 14.6406	-11.373 score on a scale Standard Deviation 16.1736	-10.915 score on a scale Standard Deviation 20.8181	-7.780 score on a scale Standard Deviation 16.2905
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-8.677 score on a scale Standard Deviation 14.0686	-9.055 score on a scale Standard Deviation 15.1680	-10.831 score on a scale Standard Deviation 20.7975	-6.600 score on a scale Standard Deviation 16.3039
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-9.077 score on a scale Standard Deviation 13.8200	-10.527 score on a scale Standard Deviation 18.0938	-9.054 score on a scale Standard Deviation 20.5279	-6.240 score on a scale Standard Deviation 15.4074
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-9.122 score on a scale Standard Deviation 13.6836	-12.956 score on a scale Standard Deviation 19.9469	-10.985 score on a scale Standard Deviation 21.6004	-5.359 score on a scale Standard Deviation 15.1614

SECONDARY outcome

Timeframe: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10) and physician global assessment of disease activity (score range as 0-10). Total score ranged between 0-76. CDAI score of 22 or above=high disease activity, a value \>10 and \<=22=moderate disease activity, a value \<=10=low disease activity, and a value \<=2.8=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Baseline	28.687 score on a scale Standard Deviation 13.2790	32.486 score on a scale Standard Deviation 15.4890	30.657 score on a scale Standard Deviation 9.4928	32.833 score on a scale Standard Deviation 12.8294	27.492 score on a scale Standard Deviation 11.0621	31.918 score on a scale Standard Deviation 17.1251	29.969 score on a scale Standard Deviation 9.5103	28.250 score on a scale Standard Deviation 6.6991
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 12	-8.653 score on a scale Standard Deviation 11.3262	-7.986 score on a scale Standard Deviation 17.5102	-7.714 score on a scale Standard Deviation 12.9650	-13.192 score on a scale Standard Deviation 8.6300	-9.438 score on a scale Standard Deviation 11.8829	-9.645 score on a scale Standard Deviation 19.0353	-7.831 score on a scale Standard Deviation 13.4867	-13.410 score on a scale Standard Deviation 8.7252
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-14.123 score on a scale Standard Deviation 14.6710	-13.964 score on a scale Standard Deviation 20.1448	-7.300 score on a scale Standard Deviation 15.9008	-11.980 score on a scale Standard Deviation 12.1211
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 16	-11.807 score on a scale Standard Deviation 12.8912	-12.279 score on a scale Standard Deviation 11.3618	-8.600 score on a scale Standard Deviation 13.6702	-15.550 score on a scale Standard Deviation 11.7076	-11.985 score on a scale Standard Deviation 13.8258	-13.709 score on a scale Standard Deviation 12.4778	-8.354 score on a scale Standard Deviation 14.1961	-14.570 score on a scale Standard Deviation 10.3295
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-10.300 score on a scale Standard Deviation 12.7026	-13.245 score on a scale Standard Deviation 19.5791	-10.046 score on a scale Standard Deviation 19.5472	-6.330 score on a scale Standard Deviation 14.3787
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 4	-7.947 score on a scale Standard Deviation 9.5817	-9.593 score on a scale Standard Deviation 11.0959	-6.586 score on a scale Standard Deviation 12.2036	-10.400 score on a scale Standard Deviation 6.4684	-8.292 score on a scale Standard Deviation 10.1373	-9.373 score on a scale Standard Deviation 11.9883	-6.092 score on a scale Standard Deviation 12.5557	-9.770 score on a scale Standard Deviation 6.4534
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 8	-10.200 score on a scale Standard Deviation 9.0094	-10.807 score on a scale Standard Deviation 18.0182	-5.493 score on a scale Standard Deviation 13.6155	-13.433 score on a scale Standard Deviation 5.8262	-10.077 score on a scale Standard Deviation 9.6871	-11.845 score on a scale Standard Deviation 20.2785	-4.785 score on a scale Standard Deviation 13.9004	-13.000 score on a scale Standard Deviation 6.1248
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 20	-12.360 score on a scale Standard Deviation 13.3098	-13.129 score on a scale Standard Deviation 14.0345	-7.400 score on a scale Standard Deviation 14.5217	-17.592 score on a scale Standard Deviation 12.6565	-13.069 score on a scale Standard Deviation 14.2281	-14.864 score on a scale Standard Deviation 15.4843	-7.638 score on a scale Standard Deviation 15.0861	-15.130 score on a scale Standard Deviation 8.6208
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 24	-14.320 score on a scale Standard Deviation 12.8371	-11.779 score on a scale Standard Deviation 16.9787	-6.679 score on a scale Standard Deviation 14.8931	-13.983 score on a scale Standard Deviation 12.3963	-15.331 score on a scale Standard Deviation 13.5575	-13.255 score on a scale Standard Deviation 19.0433	-6.862 score on a scale Standard Deviation 15.4849	-12.320 score on a scale Standard Deviation 11.8315
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-12.646 score on a scale Standard Deviation 14.8310	-11.945 score on a scale Standard Deviation 18.0326	-7.585 score on a scale Standard Deviation 17.9281	-11.580 score on a scale Standard Deviation 12.9276
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-13.377 score on a scale Standard Deviation 14.4734	-14.755 score on a scale Standard Deviation 19.2637	-7.438 score on a scale Standard Deviation 17.2899	-9.970 score on a scale Standard Deviation 16.6191
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-12.192 score on a scale Standard Deviation 14.5243	-14.200 score on a scale Standard Deviation 18.3184	-9.792 score on a scale Standard Deviation 17.3534	-8.960 score on a scale Standard Deviation 16.2228
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-12.354 score on a scale Standard Deviation 16.1397	-14.891 score on a scale Standard Deviation 19.2430	-8.785 score on a scale Standard Deviation 18.0594	-7.680 score on a scale Standard Deviation 16.0389
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-12.677 score on a scale Standard Deviation 14.3445	-15.282 score on a scale Standard Deviation 20.3093	-8.692 score on a scale Standard Deviation 17.4611	-6.160 score on a scale Standard Deviation 14.0400
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-9.300 score on a scale Standard Deviation 12.3597	-14.936 score on a scale Standard Deviation 21.9162	-9.208 score on a scale Standard Deviation 18.0779	-9.200 score on a scale Standard Deviation 15.1983
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-10.823 score on a scale Standard Deviation 13.4309	-15.327 score on a scale Standard Deviation 21.3345	-8.138 score on a scale Standard Deviation 17.6150	-7.730 score on a scale Standard Deviation 14.7041
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-10.415 score on a scale Standard Deviation 13.4300	-11.955 score on a scale Standard Deviation 15.8809	-9.877 score on a scale Standard Deviation 18.6515	-8.470 score on a scale Standard Deviation 15.7053
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-9.785 score on a scale Standard Deviation 12.9341	-9.527 score on a scale Standard Deviation 14.8393	-9.962 score on a scale Standard Deviation 19.4745	-7.370 score on a scale Standard Deviation 15.5947
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-10.523 score on a scale Standard Deviation 12.9377	-10.927 score on a scale Standard Deviation 17.8324	-7.954 score on a scale Standard Deviation 18.5732	-6.910 score on a scale Standard Deviation 14.6880
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 2	-6.087 score on a scale Standard Deviation 7.2870	-5.629 score on a scale Standard Deviation 6.6070	-5.714 score on a scale Standard Deviation 9.0823	-8.942 score on a scale Standard Deviation 8.1025	-6.515 score on a scale Standard Deviation 7.7685	-6.100 score on a scale Standard Deviation 7.3778	-5.908 score on a scale Standard Deviation 9.4231	-6.530 score on a scale Standard Deviation 6.2243

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The Disease Activity Score Based on 28-joints Count-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to \<=5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 4 · Moderate Response	3 Participants	4 Participants	4 Participants	5 Participants	2 Participants	3 Participants	4 Participants	5 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 12 · Moderate Response	5 Participants	4 Participants	5 Participants	7 Participants	5 Participants	3 Participants	5 Participants	7 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 12 · No Response	9 Participants	10 Participants	7 Participants	5 Participants	7 Participants	8 Participants	6 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 16 · No Response	7 Participants	8 Participants	8 Participants	5 Participants	6 Participants	6 Participants	7 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 20 · Good Response	3 Participants	1 Participants	2 Participants	2 Participants	3 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 20 · Moderate Response	8 Participants	6 Participants	4 Participants	5 Participants	7 Participants	5 Participants	4 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 24 · Good Response	2 Participants	2 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 36 · Good Response	—	—	—	—	2 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 40 · Good Response	—	—	—	—	3 Participants	5 Participants	2 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 48 · Moderate Response	—	—	—	—	8 Participants	2 Participants	2 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 52 · Moderate Response	—	—	—	—	6 Participants	2 Participants	3 Participants	6 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 56 · Moderate Response	—	—	—	—	6 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 56 · No Response	—	—	—	—	5 Participants	5 Participants	8 Participants	6 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 72 · Good Response	—	—	—	—	1 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 2 · Good Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 2 · Moderate Response	2 Participants	4 Participants	4 Participants	4 Participants	2 Participants	4 Participants	4 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 2 · No Response	13 Participants	10 Participants	10 Participants	8 Participants	11 Participants	7 Participants	9 Participants	6 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 4 · Good Response	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 4 · No Response	10 Participants	10 Participants	9 Participants	7 Participants	9 Participants	8 Participants	8 Participants	5 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 8 · Good Response	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 8 · Moderate Response	4 Participants	5 Participants	5 Participants	7 Participants	3 Participants	4 Participants	4 Participants	7 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 8 · No Response	10 Participants	8 Participants	9 Participants	5 Participants	9 Participants	6 Participants	9 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 12 · Good Response	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 16 · Good Response	3 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 16 · Moderate Response	5 Participants	6 Participants	5 Participants	5 Participants	5 Participants	5 Participants	5 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 20 · No Response	4 Participants	7 Participants	8 Participants	5 Participants	3 Participants	5 Participants	7 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 24 · Moderate Response	8 Participants	2 Participants	5 Participants	6 Participants	8 Participants	2 Participants	5 Participants	5 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 24 · No Response	5 Participants	10 Participants	8 Participants	4 Participants	3 Participants	7 Participants	7 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 28 · Good Response	—	—	—	—	1 Participants	4 Participants	2 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 28 · Moderate Response	—	—	—	—	8 Participants	3 Participants	4 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 28 · No Response	—	—	—	—	4 Participants	4 Participants	7 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 32 · Good Response	—	—	—	—	1 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 32 · Moderate Response	—	—	—	—	5 Participants	3 Participants	1 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 32 · No Response	—	—	—	—	7 Participants	6 Participants	9 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 36 · Moderate Response	—	—	—	—	8 Participants	2 Participants	5 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 36 · No Response	—	—	—	—	3 Participants	6 Participants	7 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 40 · Moderate Response	—	—	—	—	5 Participants	0 Participants	5 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 40 · No Response	—	—	—	—	5 Participants	6 Participants	6 Participants	5 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 44 · Good Response	—	—	—	—	2 Participants	4 Participants	1 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 44 · Moderate Response	—	—	—	—	6 Participants	1 Participants	5 Participants	5 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 44 · No Response	—	—	—	—	5 Participants	6 Participants	7 Participants	4 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 48 · Good Response	—	—	—	—	1 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 48 · No Response	—	—	—	—	4 Participants	5 Participants	8 Participants	5 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 52 · Good Response	—	—	—	—	1 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 52 · No Response	—	—	—	—	6 Participants	5 Participants	7 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 56 · Good Response	—	—	—	—	2 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 60 · Good Response	—	—	—	—	1 Participants	3 Participants	3 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 60 · Moderate Response	—	—	—	—	7 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 60 · No Response	—	—	—	—	5 Participants	6 Participants	7 Participants	5 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 64 · Good Response	—	—	—	—	1 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 64 · Moderate Response	—	—	—	—	6 Participants	2 Participants	4 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 64 · No Response	—	—	—	—	6 Participants	6 Participants	7 Participants	7 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 68 · Good Response	—	—	—	—	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 68 · Moderate Response	—	—	—	—	7 Participants	4 Participants	4 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 68 · No Response	—	—	—	—	6 Participants	5 Participants	8 Participants	7 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 72 · Moderate Response	—	—	—	—	5 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR Response at Week 72 · No Response	—	—	—	—	7 Participants	5 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The Disease Activity Score Based on 28-joints Count-CRP based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to \<=5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 2 · Moderate response	1 Participants	1 Participants	3 Participants	4 Participants	1 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 2 · No response	14 Participants	13 Participants	11 Participants	8 Participants	12 Participants	10 Participants	10 Participants	7 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 4 · Good response	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 4 · Moderate response	3 Participants	4 Participants	3 Participants	4 Participants	2 Participants	3 Participants	3 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 4 · No response	10 Participants	10 Participants	10 Participants	7 Participants	9 Participants	8 Participants	9 Participants	5 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 8 · Good response	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 8 · Moderate response	6 Participants	4 Participants	5 Participants	6 Participants	5 Participants	3 Participants	4 Participants	6 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 8 · No response	9 Participants	9 Participants	9 Participants	5 Participants	8 Participants	7 Participants	9 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 12 · Good response	1 Participants	0 Participants	2 Participants	3 Participants	1 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 12 · Moderate response	4 Participants	4 Participants	3 Participants	3 Participants	4 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 12 · No response	10 Participants	10 Participants	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 16 · Good response	3 Participants	1 Participants	2 Participants	4 Participants	2 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 16 · Moderate response	6 Participants	4 Participants	4 Participants	3 Participants	6 Participants	3 Participants	4 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 16 · No response	6 Participants	9 Participants	8 Participants	5 Participants	5 Participants	7 Participants	7 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 20 · Good response	2 Participants	2 Participants	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 20 · Moderate response	9 Participants	5 Participants	3 Participants	4 Participants	8 Participants	4 Participants	3 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 20 · No response	4 Participants	7 Participants	9 Participants	5 Participants	3 Participants	5 Participants	8 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 24 · Good response	3 Participants	1 Participants	1 Participants	4 Participants	3 Participants	1 Participants	1 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 24 · Moderate response	8 Participants	3 Participants	4 Participants	4 Participants	8 Participants	3 Participants	4 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 24 · No response	4 Participants	10 Participants	9 Participants	4 Participants	2 Participants	7 Participants	8 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 28 · Good response	—	—	—	—	1 Participants	3 Participants	2 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 28 · Moderate response	—	—	—	—	9 Participants	3 Participants	4 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 28 · No response	—	—	—	—	3 Participants	5 Participants	7 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 32 · Good response	—	—	—	—	1 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 32 · Moderate response	—	—	—	—	7 Participants	2 Participants	2 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 32 · No response	—	—	—	—	5 Participants	6 Participants	8 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 36 · Good response	—	—	—	—	3 Participants	4 Participants	1 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 36 · Moderate response	—	—	—	—	7 Participants	2 Participants	4 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 60 · No response	—	—	—	—	6 Participants	6 Participants	8 Participants	5 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 68 · No response	—	—	—	—	6 Participants	5 Participants	8 Participants	7 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 72 · Moderate response	—	—	—	—	3 Participants	3 Participants	3 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 44 · Good response	—	—	—	—	3 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 44 · Moderate response	—	—	—	—	5 Participants	1 Participants	4 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 44 · No response	—	—	—	—	5 Participants	6 Participants	7 Participants	5 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 48 · Good response	—	—	—	—	1 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 2 · Good response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 36 · No response	—	—	—	—	3 Participants	5 Participants	8 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 40 · Good response	—	—	—	—	2 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 40 · Moderate response	—	—	—	—	5 Participants	4 Participants	3 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 40 · No response	—	—	—	—	6 Participants	6 Participants	8 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 48 · Moderate response	—	—	—	—	6 Participants	3 Participants	3 Participants	4 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 48 · No response	—	—	—	—	6 Participants	5 Participants	8 Participants	5 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 52 · Good response	—	—	—	—	1 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 52 · Moderate response	—	—	—	—	6 Participants	3 Participants	4 Participants	6 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 52 · No response	—	—	—	—	6 Participants	5 Participants	7 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 56 · Good response	—	—	—	—	2 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 56 · Moderate response	—	—	—	—	6 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 56 · No response	—	—	—	—	5 Participants	5 Participants	9 Participants	6 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 60 · Good response	—	—	—	—	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 60 · Moderate response	—	—	—	—	5 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 64 · Good response	—	—	—	—	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 64 · Moderate response	—	—	—	—	4 Participants	2 Participants	4 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 64 · No response	—	—	—	—	7 Participants	7 Participants	6 Participants	6 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 68 · Good response	—	—	—	—	1 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 68 · Moderate response	—	—	—	—	6 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 72 · Good response	—	—	—	—	2 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 72 · No response	—	—	—	—	8 Participants	5 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 86 or above=high disease activity, a value \>11 and \<=26=moderate disease activity, a value \>=3.4 and \<=11=low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score \<=3.3. Data for Core Treatment Phase from Week 0-10 is reported according to participant's re-randomization in four arms at Week 12. Data reported for Extension Phase from Week 2 to Week 24, is same data for Core Treatment Phase, but excluding participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 2	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 8	6.7 percentage of participants Interval 0.0 to 19.29	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 32	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 40	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 44	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 48	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 52	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	27.3 percentage of participants Interval 0.95 to 53.59	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 12	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 16	6.7 percentage of participants Interval 0.0 to 19.29	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	8.3 percentage of participants Interval 0.0 to 23.97	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 20	6.7 percentage of participants Interval 0.0 to 19.29	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	8.3 percentage of participants Interval 0.0 to 23.97	7.7 percentage of participants Interval 0.0 to 22.18	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 24	6.7 percentage of participants Interval 0.0 to 19.29	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	8.3 percentage of participants Interval 0.0 to 23.97	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 28	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 36	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 56	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 60	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 64	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 68	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 72	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	27.3 percentage of participants Interval 0.95 to 53.59	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), and physician global assessment of disease activity score (score range as 0-10). Total score ranged between 0-76. CDAI score of 76 or above=high disease activity, a value \>10 and \<=22=moderate disease activity, a value \>2.9 and \<=10=low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score \<=2.8. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 2	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 12	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 32	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 36	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 52	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	27.3 percentage of participants Interval 0.95 to 53.59	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 4	6.7 percentage of participants Interval 0.0 to 19.29	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 8	6.7 percentage of participants Interval 0.0 to 19.29	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 16	6.7 percentage of participants Interval 0.0 to 19.29	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 20	6.7 percentage of participants Interval 0.0 to 19.29	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	8.3 percentage of participants Interval 0.0 to 23.97	7.7 percentage of participants Interval 0.0 to 22.18	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 24	6.7 percentage of participants Interval 0.0 to 19.29	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	8.3 percentage of participants Interval 0.0 to 23.97	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 28	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	20.0 percentage of participants Interval 0.0 to 44.79
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 40	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 44	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 48	—	—	—	—	7.7 percentage of participants Interval 0.0 to 22.18	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 56	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 60	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 64	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 68	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 72	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59

SECONDARY outcome

Timeframe: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Boolean remission criteria was defined as: tender joint count 68 \<=1; swollen joint count 66 \<=1; CRP \<=1 mg/dL; and disease activity assessments VAS (mm) by participants \<=10. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Outcome measures

Outcome measures
Measure	Core Treatment Phase: Placebo n=15 Participants During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=14 Participants During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 Participants Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 Participants Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 Participants Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 28	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 2	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 4	6.7 percentage of participants Interval 0.0 to 19.29	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 8	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 12	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 16	6.7 percentage of participants Interval 0.0 to 19.29	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 20	13.3 percentage of participants Interval 0.0 to 30.54	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	8.3 percentage of participants Interval 0.0 to 23.97	15.4 percentage of participants Interval 0.0 to 35.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 24	6.7 percentage of participants Interval 0.0 to 19.29	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.63	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 32	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 22.18	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 36	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 40	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 44	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 48	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 52	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	7.7 percentage of participants Interval 0.0 to 22.18	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 56	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	18.2 percentage of participants Interval 0.0 to 40.97	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 60	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 64	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 68	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	10.0 percentage of participants Interval 0.0 to 28.59
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 72	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	9.1 percentage of participants Interval 0.0 to 26.08	15.4 percentage of participants Interval 0.0 to 35.0	10.0 percentage of participants Interval 0.0 to 28.59

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Core Treatment Phase: Placebo n=33 participants at risk During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=31 participants at risk During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: Placebo Then E6011 200 mg n=15 participants at risk Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: Placebo Then E6011 400 mg n=14 participants at risk Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 participants at risk Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 participants at risk Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 participants at risk Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 participants at risk Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 participants at risk Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 participants at risk Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Hepatobiliary disorders Cholecystitis acute	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Hepatobiliary disorders Hepatic function abnormal	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Sudden death	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Joint destruction	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Other adverse events

Other adverse events
Measure	Core Treatment Phase: Placebo n=33 participants at risk During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: E6011 400 mg n=31 participants at risk During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.	Core Treatment Phase: Placebo Then E6011 200 mg n=15 participants at risk Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: Placebo Then E6011 400 mg n=14 participants at risk Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 200 mg n=14 participants at risk Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Core Treatment Phase: E6011 400 mg Then E6011 400 mg n=12 participants at risk Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.	Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg n=13 participants at risk Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg n=11 participants at risk Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg n=13 participants at risk Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.	Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg n=10 participants at risk Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Infections and infestations Bronchitis	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Cystitis	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Blood and lymphatic system disorders Anaemia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Ear and labyrinth disorders Tinnitus	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Ear and labyrinth disorders Eustachian tube patulous	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Stomatitis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.5% 2/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Faeces soft	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Abdominal pain upper	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	18.2% 2/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Cheilitis	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Dental caries	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	13.3% 2/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	23.1% 3/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Diarrhoea	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Gastritis	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Mouth ulceration	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Periodontal disease	6.1% 2/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Injection site erythema	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.5% 2/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	14.3% 2/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Injection site reaction	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Face oedema	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Injection site pain	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Injection site warmth	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Hepatobiliary disorders Hepatic function abnormal	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	13.3% 2/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	30.0% 3/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Breast abscess	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Gastroenteritis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Oral herpes	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Pharyngitis	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Sinusitis	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Upper respiratory tract infection	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	14.3% 2/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Ligament sprain	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	23.1% 3/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations Blood creatine phosphokinase increased	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.5% 2/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations Alanine aminotransferase increased	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations Aspartate aminotransferase increased	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations Cell marker increased	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations Liver function test increased	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	3.2% 1/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Joint destruction	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Rash	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	14.3% 2/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	18.2% 2/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	3.0% 1/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Eye disorders Dry eye	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Eye disorders Conjunctival haemorrhage	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Enterocolitis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Nausea	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Constipation	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Injection site swelling	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Injection site haemorrhage	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Immune system disorders Seasonal allergy	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Gastroenteritis norovirus	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Herpes zoster	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Pneumonia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Otitis media	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Periodontitis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations Amylase increased	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	27.3% 3/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Syncope	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Psychiatric disorders Insomnia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	23.1% 3/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Renal and urinary disorders Hypertonic bladder	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	8.3% 1/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.1% 1/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	23.1% 3/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Vascular disorders Hypertension	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	6.7% 1/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Ear and labyrinth disorders Vertigo positional	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Endocrine disorders Cushingoid	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Dental necrosis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Gastrointestinal disorders Toothache	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
General disorders Pyrexia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Nasopharyngitis	27.3% 9/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	12.9% 4/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	13.3% 2/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	28.6% 4/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	28.6% 4/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	33.3% 4/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	53.8% 7/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	36.4% 4/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	61.5% 8/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	50.0% 5/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Paronychia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	20.0% 2/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Influenza	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Tinea pedis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Atypical mycobacterial infection	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Bacterial diarrhoea	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Conjunctivitis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Dermatophytosis of nail	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Gingivitis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Infections and infestations Oesophageal candidiasis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Contusion	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Fall	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations Blood creatinine increased	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Investigations White blood cell count decreased	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Metabolism and nutrition disorders Hypovitaminosis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Dyskinesia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Headache	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Hypoaesthesia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Migraine	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Nervous system disorders Neuralgia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Reproductive system and breast disorders Menorrhagia	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	10.0% 1/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	9.1% 1/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	15.4% 2/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Chloasma	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Vascular disorders Poor peripheral circulation	0.00% 0/33 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/31 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/15 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/14 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/12 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	7.7% 1/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/11 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/13 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.	0.00% 0/10 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104) SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Additional Information

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