Trial Outcomes & Findings for A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (NCT NCT03843125)

NCT ID: NCT03843125

Last Updated: 2023-05-16

Results Overview

Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1147 participants
• Primary outcome timeframe: Week 134
• Results posted on: 2023-05-16

Participant Flow

Participants who completed originating study [I4V-MC-JAHZ (NCT03616912) or Study I4V-MC-JAIA (NCT03616964)] were enrolled in this study.

Participants who were randomized to placebo during originating Study I4V-MC-JAHZ (NCT03616912) or Study I4V-MC-JAIA (NCT03616964) were randomized 1:1 to receive baricitinib 4-milligrams (mg) or baricitinib 2-mg once daily (QD), administered orally.

Participant milestones

Measure	2 Milligrams (mg) Baricitinib Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Overall Study STARTED	388	379	189	191
Overall Study Safety Population	388	378	189	191
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	388	379	189	191

Reasons for withdrawal

Measure	2 Milligrams (mg) Baricitinib Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Overall Study Adverse Event	17	13	5	9
Overall Study Death	0	6	2	0
Overall Study Lack of Efficacy	14	11	9	4
Overall Study Lost to Follow-up	3	4	0	2
Overall Study Other	12	14	3	4
Overall Study Due to Epidemic/Pandemic	1	0	0	0
Overall Study Study Terminated by Sponsor	318	318	163	163
Overall Study Withdrawal by Subject	23	12	6	9
Overall Study Missing data	0	1	1	0

Baseline Characteristics

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Measure	2 mg Baricitinib n=388 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally QD.	4 mg Baricitinib n=379 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.	Total n=1147 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 12.68 • n=5 Participants	43.8 years STANDARD_DEVIATION 12.03 • n=7 Participants	43.8 years STANDARD_DEVIATION 11.85 • n=5 Participants	43.5 years STANDARD_DEVIATION 13.22 • n=4 Participants	43.7 years STANDARD_DEVIATION 12.41 • n=21 Participants
Sex: Female, Male Female	361 Participants n=5 Participants	357 Participants n=7 Participants	181 Participants n=5 Participants	176 Participants n=4 Participants	1075 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	8 Participants n=5 Participants	15 Participants n=4 Participants	72 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	21 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	61 Participants n=21 Participants
Race (NIH/OMB) Asian	79 Participants n=5 Participants	77 Participants n=7 Participants	44 Participants n=5 Participants	41 Participants n=4 Participants	241 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	36 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants	106 Participants n=21 Participants
Race (NIH/OMB) White	249 Participants n=5 Participants	241 Participants n=7 Participants	109 Participants n=5 Participants	115 Participants n=4 Participants	714 Participants n=21 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment United States	66 Participants n=5 Participants	68 Participants n=7 Participants	28 Participants n=5 Participants	30 Participants n=4 Participants	192 Participants n=21 Participants
Region of Enrollment Czechia	7 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment Russia	19 Participants n=5 Participants	16 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	57 Participants n=21 Participants
Region of Enrollment Greece	8 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment South Korea	7 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Austria	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment China	17 Participants n=5 Participants	18 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	51 Participants n=21 Participants
Region of Enrollment Poland	27 Participants n=5 Participants	28 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	79 Participants n=21 Participants
Region of Enrollment Brazil	17 Participants n=5 Participants	19 Participants n=7 Participants	14 Participants n=5 Participants	10 Participants n=4 Participants	60 Participants n=21 Participants
Region of Enrollment France	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Serbia	18 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	43 Participants n=21 Participants
Region of Enrollment Chile	12 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	27 Participants n=21 Participants
Region of Enrollment Croatia	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Colombia	11 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	39 Participants n=21 Participants
Region of Enrollment Argentina	21 Participants n=5 Participants	23 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	73 Participants n=21 Participants
Region of Enrollment Romania	11 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	24 Participants n=21 Participants
Region of Enrollment Hungary	16 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	39 Participants n=21 Participants
Region of Enrollment Japan	6 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	24 Participants n=21 Participants
Region of Enrollment Philippines	13 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	33 Participants n=21 Participants
Region of Enrollment United Kingdom	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Switzerland	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment India	20 Participants n=5 Participants	20 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	65 Participants n=21 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment Belgium	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Taiwan	8 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
Region of Enrollment Italy	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Mexico	40 Participants n=5 Participants	40 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants	112 Participants n=21 Participants
Region of Enrollment South Africa	13 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	34 Participants n=21 Participants
Region of Enrollment Israel	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Australia	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	17 Participants n=21 Participants
Region of Enrollment Germany	9 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	29 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 134

Population: All participants who received at least one dose of study drug.

Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time.

A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Measure	2 mg Baricitinib n=388 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=378 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	61.9 Percentage of Participants	68.8 Percentage of Participants	65.1 Percentage of Participants	64.4 Percentage of Participants

PRIMARY outcome

Timeframe: Week 134

Population: All participants who received at least one dose of study drug.

Percentage of Participants with AESIs. AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies.

Outcome measures

Measure	2 mg Baricitinib n=388 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=378 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants With Adverse Events of Special Interest (AESIs) Positively adjudicated ATE	0.3 Percentage of participants	0.8 Percentage of participants	0.5 Percentage of participants	0.5 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Infections	38.4 Percentage of participants	42.1 Percentage of participants	36.5 Percentage of participants	35.1 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Positively adjudicated VTE	0.3 Percentage of participants	1.1 Percentage of participants	0.5 Percentage of participants	0.5 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Positively adjudicated MACE	0.3 Percentage of participants	0.8 Percentage of participants	0.5 Percentage of participants	0.5 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Other positively adjudicated cardiovascular events	0.3 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants	0.5 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Death	0 Percentage of participants	1.6 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Anaphylactic reactions	3.6 Percentage of participants	4.2 Percentage of participants	5.8 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Hypersensitivity	3.6 Percentage of participants	4.2 Percentage of participants	5.8 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Angioedema	1.3 Percentage of participants	0.8 Percentage of participants	1.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With Adverse Events of Special Interest (AESIs) Malignancies	0.5 Percentage of participants	0.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Week 134

Population: All participants who received at least one dose of study drug.

Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above.

A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Outcome measures

Measure	2 mg Baricitinib n=388 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=378 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants With Serious Adverse Events (SAEs)	11.1 Percentage of Participants	13.5 Percentage of Participants	11.1 Percentage of Participants	11.5 Percentage of Participants

PRIMARY outcome

Timeframe: Week 134

Population: All participants who received at least one dose of study drug.

Percentage of participants with temporary investigational product interruptions.

Outcome measures

Measure	2 mg Baricitinib n=388 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=378 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants With Temporary Investigational Product Interruptions	19.1 Percentage of Participants	24.6 Percentage of Participants	18.5 Percentage of Participants	23.6 Percentage of Participants

PRIMARY outcome

Timeframe: Week 134

Population: All participants who received at least one dose of study drug.

Percentage of participants with permanent investigational product discontinuations.

Outcome measures

Measure	2 mg Baricitinib n=388 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=378 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants With Permanent Investigational Product Discontinuations	5.2 Percentage of Participants	5.8 Percentage of Participants	4.2 Percentage of Participants	5.8 Percentage of Participants

SECONDARY outcome

Timeframe: Week 134

Population: All randomized participants who had SLEDAI-2K score of \>=4 at baseline.

SRI-4 response defined as 1)greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale).

SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assesses disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).

Outcome measures

Measure	2 mg Baricitinib n=388 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=379 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=129 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=131 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: All participants who received at least one dose of study drug and had SLEDAI-2K score of \>=4 at baseline. Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination).

Percentage of participants achieving a LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily.

Outcome measures

Measure	2 mg Baricitinib n=289 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=261 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=98 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=100 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)	29.8 Percentage of participants	33.0 Percentage of participants	19.4 Percentage of participants	26.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.

Change from baseline in prednisone dose.

Outcome measures

Measure	2 mg Baricitinib n=235 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=225 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=115 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=121 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Change From Baseline in Prednisone Dose	2.35 milligrams (mg) Standard Error 0.305	2.27 milligrams (mg) Standard Error 0.316	1.68 milligrams (mg) Standard Error 0.426	1.00 milligrams (mg) Standard Error 0.419

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.

The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. The annualized flare rate is calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25.

Outcome measures

Measure	2 mg Baricitinib n=289 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=261 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=136 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=143 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate	0.978 flares per year	0.926 flares per year	0.894 flares per year	0.746 flares per year

SECONDARY outcome

Timeframe: Week 48

Population: All participants with CLASI Total Activity Score \>= 10 at baseline. Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination).

The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.

Outcome measures

Measure	2 mg Baricitinib n=59 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=50 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=5 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=5 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score	55.9 Percentage of participants	64.0 Percentage of participants	60.0 Percentage of participants	20.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.

The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

Outcome measures

Measure	2 mg Baricitinib n=230 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=217 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=113 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=119 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Change From Baseline in Tender Joint Count	-5.68 tender joints Standard Error 0.281	-5.85 tender joints Standard Error 0.292	-3.62 tender joints Standard Error 0.383	-3.73 tender joints Standard Error 0.376

SECONDARY outcome

Timeframe: Baseline trough Week 48

Population: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.

The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

Outcome measures

Measure	2 mg Baricitinib n=230 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=217 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=113 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=119 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Change From Baseline in Swollen Joint Count	-4.03 swollen joints Standard Error 0.191	-4.01 swollen joints Standard Error 0.196	-3.19 swollen joints Standard Error 0.264	-2.94 swollen joints Standard Error 0.257

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.

The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0 indicates no damage. Total maximum score is 47 and increasing score indicates increasing disease severity.

Outcome measures

Measure	2 mg Baricitinib n=235 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=226 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=115 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=121 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score	-0.03 Score on a scale Standard Deviation 0.569	-0.04 Score on a scale Standard Deviation 0.544	-0.04 Score on a scale Standard Deviation 0.754	-0.06 Score on a scale Standard Deviation 0.505

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.

Change from baseline in Worst Pain NRS. It is assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". Overall severity of a patient's pain is indicated by selecting the number that best describes the worst level of pain during the past 7 days.

Outcome measures

Measure	2 mg Baricitinib n=220 Participants Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).	4 mg Baricitinib n=207 Participants Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=111 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=118 Participants Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)	-0.96 Score on a scale Standard Error 0.167	-1.23 Score on a scale Standard Error 0.173	-0.55 Score on a scale Standard Error 0.222	-0.83 Score on a scale Standard Error 0.218

Adverse Events

2 mg Baricitinib

Serious events: 43 serious events

Other events: 54 other events

Deaths: 0 deaths

4 mg Baricitinib

Serious events: 53 serious events

Other events: 54 other events

Deaths: 6 deaths

Placebo to 2 mg Baricitinib

Serious events: 21 serious events

Other events: 35 other events

Deaths: 2 deaths

Placebo to 4 mg Baricitinib

Serious events: 22 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	2 mg Baricitinib n=388 participants at risk Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally QD.	4 mg Baricitinib n=378 participants at risk Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 participants at risk Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 participants at risk Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Blood and lymphatic system disorders Immune thrombocytopenia	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Angina unstable	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial flutter	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Cardiac failure congestive	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.52% 2/388 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Scleritis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.52% 2/388 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Bile duct stone	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.0% 2/191 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Immune-mediated hepatic disorder	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Acinetobacter sepsis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Arthritis bacterial	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Atypical pneumonia	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 2/378 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 7/378 • Number of events 7 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/189 • Number of events 3 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19 pneumonia	1.3% 5/388 • Number of events 5 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 5/378 • Number of events 5 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/191 • Number of events 3 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Endocarditis bacterial	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Escherichia pyelonephritis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/191 • Number of events 3 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Escherichia urinary tract infection	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis salmonella	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Herpes zoster	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Herpes zoster meningitis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Infection	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Meningitis bacterial	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Osteomyelitis	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	1.0% 4/388 • Number of events 4 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia parainfluenzae viral	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia viral	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Post procedural infection	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pulmonary tuberculosis	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pyelonephritis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pyelonephritis acute	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Renal abscess	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sinusitis	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tubo-ovarian abscess	0.28% 1/361 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/356 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/181 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/176 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 2/378 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 3 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.0% 2/191 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Wrist fracture	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Biopsy	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Clostridium test positive	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Herpes simplex test positive	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations International normalised ratio increased	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.0% 2/191 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint instability	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/189 • Number of events 3 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.52% 2/388 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 5/378 • Number of events 6 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/191 • Number of events 3 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendon sheath disorder	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone b-cell lymphoma (malt type)	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Her2 positive breast cancer	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/361 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/356 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.55% 1/181 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/176 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Autoimmune neuropathy	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Central nervous system lupus	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebral infarction	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebral ischaemia	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cognitive disorder	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Ischaemic stroke	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Seizure	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/361 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.28% 1/356 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/181 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/176 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Acute psychosis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depression suicidal	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Hallucination	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Suicide attempt	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Calculus urinary	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Glomerulonephritis membranous	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Lupus nephritis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Proteinuria	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Renal impairment	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Cervical dysplasia	0.55% 2/361 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.28% 1/356 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/181 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/176 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Endometriosis	0.00% 0/361 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.28% 1/356 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/181 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/176 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.52% 2/388 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 2/378 • Number of events 2 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rosacea	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Stevens-johnson syndrome	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Cervical conisation	0.00% 0/361 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/356 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.55% 1/181 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/176 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Cholecystectomy	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Fasciotomy	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Accelerated hypertension	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.53% 1/189 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Aortic stenosis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.26% 1/388 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Embolism arterial	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Jugular vein thrombosis	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/378 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/191 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Raynaud's phenomenon	0.00% 0/388 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/378 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/189 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.52% 1/191 • Number of events 1 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Measure	2 mg Baricitinib n=388 participants at risk Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally QD.	4 mg Baricitinib n=378 participants at risk Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.	Placebo to 2 mg Baricitinib n=189 participants at risk Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.	Placebo to 4 mg Baricitinib n=191 participants at risk Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Infections and infestations Covid-19	9.0% 35/388 • Number of events 35 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.5% 32/378 • Number of events 33 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 21/189 • Number of events 22 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.0% 23/191 • Number of events 25 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	5.2% 20/388 • Number of events 28 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 22/378 • Number of events 27 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.0% 17/189 • Number of events 19 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 7/191 • Number of events 8 • Baseline through Study Completion (Up to 134 Weeks) All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60