Trial Outcomes & Findings for A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL) (NCT NCT02814175)

Results Overview

Minimal disease activity (MDA) for psoriatic arthritis (PsA) was defined as fulfilling at least 5 of the following 7 criteria: tender and swollen joint counts (TJC) ≤ 1 (out of TJC68 assessed in this study), swollen joint count (SJC) ≤ 1 (out of SJC66 assessed in this study), Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3; Patient's assessment of pain visual analogue scale (VAS) ≤ 15, Patient's global assessment of disease activity (PtGA) VAS ≤ 20, Health Assessment Questionnaire Disability Index (HAQ-DI) score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

246 participants

Primary outcome timeframe

Week 16

Results posted on

2020-11-23

Participant Flow

There were 246 participants randomized; 1 participant did not receive study medication. Upon completion of Part 1, eligible participants continued to Part 2, so no additional participants were enrolled in Part 2.

Intent-To-Treat Part 1 (ITT Part 1) population comprised all participants randomized and received at least 1 dose of study medication in Part 1. ITT Long Term (ITT LT) population included all participants who continued to Part 2 and received at least 1 dose of Part 2 study medication; no additional participants were enrolled into Part 2.

Participant milestones

Participant milestones
Measure	Part 1: MTX Escalated Dose Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX Adalimumab (ADA) 40 mg every other week (eow) in combination with methotrexate (MTX) 15 mg every week (ew)	Part 2: MTX Escalated Dose Participants achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 -25 mg or highest tolerable dose every week (ew), continued with the same MTX dose	Part 2: ADA +MTX Escalated Dose Participants not achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew), received adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 20 - 25 mg or highest tolerable dose ew	Part 2: ADA Participants achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Part 1 STARTED	122	123	0	0	0	0
Part 1 COMPLETED	110	117	0	0	0	0
Part 1 NOT COMPLETED	12	6	0	0	0	0
Part 2 STARTED	0	0	15	95	54	63
Part 2 COMPLETED	0	0	15	91	52	57
Part 2 NOT COMPLETED	0	0	0	4	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: MTX Escalated Dose Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX Adalimumab (ADA) 40 mg every other week (eow) in combination with methotrexate (MTX) 15 mg every week (ew)	Part 2: ADA +MTX Escalated Dose Participants not achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew), received adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 20 - 25 mg or highest tolerable dose ew	Part 2: ADA Participants achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Part 1 Adverse Event	2	3	0	0	0
Part 1 Withdrawal Consent	8	1	0	0	0
Part 1 Lost to Follow-up	1	0	0	0	0
Part 1 Lack of Efficacy	1	2	0	0	0
Part 2 Adverse Event	0	0	1	1	2
Part 2 Withdrawal Consent	0	0	2	1	1
Part 2 Lost to Follow-up	0	0	1	0	0
Part 2 Lack of Efficacy	0	0	0	0	3

Baseline Characteristics

A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: MTX Escalated Dose n=122 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=123 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with methotrexate (MTX) 15 mg every week (ew)	Total n=245 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	48.8 years STANDARD_DEVIATION 12.69 • n=5 Participants	51.4 years STANDARD_DEVIATION 12.23 • n=7 Participants	50.1 years STANDARD_DEVIATION 12.50 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	64 Participants n=7 Participants	123 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	59 Participants n=7 Participants	122 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants	96 Participants n=7 Participants	191 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	111 Participants n=5 Participants	115 Participants n=7 Participants	226 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Intent-To-Treat Part 1 (ITT Part 1) population comprises all participants who were randomized and received at least one dose of the study medication during Part 1. Results for binary endpoints are based on non-responder imputation (NRI).

Minimal disease activity (MDA) for psoriatic arthritis (PsA) was defined as fulfilling at least 5 of the following 7 criteria: tender and swollen joint counts (TJC) ≤ 1 (out of TJC68 assessed in this study), swollen joint count (SJC) ≤ 1 (out of SJC66 assessed in this study), Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3; Patient's assessment of pain visual analogue scale (VAS) ≤ 15, Patient's global assessment of disease activity (PtGA) VAS ≤ 20, Health Assessment Questionnaire Disability Index (HAQ-DI) score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=122 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=123 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)	13.1 percentage of participants Interval 7.1 to 19.1	41.5 percentage of participants Interval 32.8 to 50.2	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1). Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

The Dermatology Life Quality Index (DLQI) score is a measure of participant's quality of life (QOL) related to skin disease.The DLQI questionnaire consists of 10 questions concerning participants' perception of the impact of skin diseases on different aspects of their health related QOL over the last week. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. The range of possible DLQI scores is 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=109 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=117 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)	-3.1 score on a scale Interval -3.85 to -2.3	-5.9 score on a scale Interval -6.7 to -5.2	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

Hands and feet bilaterally were assessed for the presence/absence of dactylitis and associated tenderness for participants with presence of dactylitis at baseline. The tender dactylitic digit count is equal to the number of swollen and painful digits (range 0 to 20). A decrease indicates improvement.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=66 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=62 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)	-0.9 count of fingers/ toes with dactylitis Interval -1.48 to -0.41	-2.8 count of fingers/ toes with dactylitis Interval -3.35 to -2.23	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity but is also used in PsA clinical trials. DAS28 is a composite score calculated using a mathematical formula based on the scores for these scales. DAS28 includes tender and swollen joint counts, PtGA, and acute phase reactant (CRP in this study). DAS28 scores range from 0 to 10, with higher scores indicating more disease activity. A larger negative change in the DAS28 score indicates greater improvement.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=108 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=114 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)	-0.9 score on a scale Interval -1.08 to -0.65	-2.0 score on a scale Interval -2.16 to -1.75	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

Psoriatic Arthritis Impact of Disease Score (PsAID) was developed by an European League Against Rheumatism (EULAR) initiative and is a validated patient self-reported tool to assess the impact of PsA on the participant's life. The PsAID is a composite score calculated using a mathematical formula based on the scores for each component. PsAID-9 was developed for clinical trials and was used in this study. The PsAID-9 is calculated based on 9 Numerical rating scales (NRS) questions that include pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, and anxiety). Each NRS is assessed as a number between 0 and 10. PsAID scores range from 0 to 10, with higher scores indicating worse status. A larger negative change in the PsAID-9 score indicates greater improvement.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=107 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=117 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)	-1.7 score on a scale Interval -2.09 to -1.28	-3.3 score on a scale Interval -3.73 to -2.95	—	—

SECONDARY outcome

Timeframe: Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

The ACR is a standard criteria originally developed to measure the effectiveness of various arthritis medications or treatments in clinical trials for RA, but is also widely used in PsA. The ACR measures improvement in tender joint count (TJC) or swollen joint count (SJC), and improvement in at least 3 of the following 5 parameters: Patient Global Assessment (PtGA), Physician's Global Assessment of Disease Activity (PhGA), physical function (using HAQ-DI) and acute phase reactant (using CRP). ACR 20/50/70 response is achieved if ≥ 20%/≥ 50%/≥ 70% improvement in tender joint count (TJC) or swollen joint count (SJC) as well as a ≥ 20%/≥ 50%/≥ 70% improvement in ≥ 3 of the other 5 parameters.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=122 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=123 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1) ACR 20	32.8 percentage of participants Interval 24.5 to 41.1	67.5 percentage of participants Interval 59.2 to 75.8	—	—
Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1) ACR 50	16.4 percentage of participants Interval 9.8 to 23.0	45.5 percentage of participants Interval 36.7 to 54.3	—	—
Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1) ACR 70	8.2 percentage of participants Interval 3.3 to 13.1	30.9 percentage of participants Interval 22.7 to 39.1	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

The Leeds Enthesitis Index (LEI) is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions for participants with presence of LEI at baseline.Tenderness on examination is recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. A decrease in LEI indicates improvement.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=89 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=92 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline	-1.1 score on a scale Interval -1.43 to -0.75	-1.9 score on a scale Interval -2.22 to -1.54	—	—

SECONDARY outcome

Timeframe: Week 32

Population: ITT Long Term (ITT LT) population comprises all participants who continued to Part 2 and received at least one dose of Part 2 study medication. No missing data imputationperformed for long term efficacy analysis except for participants who were rescued, where participants rescued prior to Week 32 are imputed as non-responders.

MDA for PsA was defined as fulfilling at least 5 of the following 7 criteria: TJC ≤ 1 (out of TJC68 assessed in this study), SJC ≤ 1 (out of SJC66 assessed in this study), PASI ≤ 1 or BSA ≤ 3; Patient's assessment of pain VAS ≤ 15, PtGA VAS ≤ 20, HAQ-DI score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=15 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=91 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA n=51 Participants Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX n=57 Participants Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Percentage of Participants in MDA in Part 2 of the Study (Week 32)	66.7 percentage of participants Interval 42.8 to 90.5	54.9 percentage of participants Interval 44.7 to 65.2	80.4 percentage of participants Interval 69.5 to 91.3	29.8 percentage of participants Interval 17.9 to 41.7

SECONDARY outcome

Timeframe: From Day 1 to week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

Psoriatic Arthritis Disease Activity Score (PASDAS) is a weighted disease activity measure developed specifically for PsA. It includes PhGA, PtGA, SF-36 PCS, SJC, TJC, Leeds enthesitis count, tender dactylitic count and hsCRP lab test. The PASDAS is a composite score calculated using a mathematical formula based on the scores for each component. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement. .

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=105 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=114 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1)	-1.2 score on a scale Interval -1.46 to -0.86	-2.8 score on a scale Interval -3.05 to -2.48	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1)

The Short Form Health Survey 36 (SF-36) is a generic measure to assess participant's general health/well-being (health related quality of life); short version 2 (SF-36v2) was used. SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise physical component of the SF-36. Scores on each item were summed and averaged (PCS; range = 0-100). Items 5-8 comprise mental component of the SF-36. Scores on each item were summed and averaged (mental component score \[MCS\]; range = 0-100). Larger values on SF-36 indicate a better condition. A positive change from Baseline in either PCS or MCS indicates improvement.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=107 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=117 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1) SF-36 PCS	4.4 score on a scale Interval 3.07 to 5.73	8.9 score on a scale Interval 7.58 to 10.15	—	—
Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1) SF-36 MCS	1.3 score on a scale Interval -0.36 to 2.97	4.4 score on a scale Interval 2.85 to 6.05	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

The HAQ-DI is a standardized measure of physical function in arthritis. The HAQ-DI questionnaire contains 20 items divided into 8 domains that measure: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=110 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=116 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in HAQ-DI Score From Baseline (Part 1)	-0.3 score on a scale Interval -0.39 to -0.21	-0.5 score on a scale Interval -0.6 to -0.42	—	—

SECONDARY outcome

Timeframe: Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

Psoriasis Area and Severity Index (PASI) provides a quantitative assessment of psoriasis lesional burden based on the amount of body surface area involved and the degree of severity of erythema, induration, and scale, weighted by body part. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. 75/90/100 denotes greater than or equal to 75%/90%/100% improvement in PASI score. A 100% reduction is considered complete clearance of psoriasis.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=87 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=78 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1) PASI 75	31.0 percentage of participants Interval 21.3 to 40.8	73.1 percentage of participants Interval 63.2 to 82.9	—	—
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1) PASI 90	18.4 percentage of participants Interval 10.3 to 26.5	57.7 percentage of participants Interval 46.7 to 68.7	—	—
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1) PASI 100	9.2 percentage of participants Interval 3.1 to 15.3	29.5 percentage of participants Interval 19.4 to 39.6	—	—

SECONDARY outcome

Timeframe: From Day 1 to Week 16

Population: ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.

Disease Activity in Psoriatic Arthritis Score (DAPSA) score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 100 centimeter \[cm\] VAS, 0=excellent and 10=poor). Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity.

Outcome measures

Outcome measures
Measure	Part 1: MTX Escalated Dose n=108 Participants Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)	Part 1: ADA + MTX n=114 Participants Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew	Part 2: ADA Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy	Part 2: ADA ew + MTX Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1)	-12.1 score on a scale Interval -15.57 to -8.69	-28.2 score on a scale Interval -31.6 to -24.87	—	—

Adverse Events

Part 1: MTX Escalated Dose

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Part 1: ADA + MTX

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Part 2: MTX Escalated Dose

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: ADA + MTX Escalated Dose

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Part 2: ADA

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: ADA ew + MTX

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: MTX Escalated Dose n=122 participants at risk Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew) (MTX 20 - 25 mg or highest tolerable dose ew)	Part 1: ADA + MTX n=123 participants at risk Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew (ADA 40 mg eow + MTX 15 mg ew	Part 2: MTX Escalated Dose n=15 participants at risk Participants achieving MDA at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose (MTX 20 - 25 mg or highest tolerable dose ew)	Part 2: ADA + MTX Escalated Dose n=95 participants at risk Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew (ADA 40 mg eow plus MTX 20 - 25 mg or highest tolerable dose ew)	Part 2: ADA n=54 participants at risk Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy (ADA 40 mg eow),	Part 2: ADA ew + MTX n=63 participants at risk Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew (ADA 40 mg ew plus MTX 15 mg ew)
Gastrointestinal disorders GASTRIC MUCOSA ERYTHEMA	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Gastrointestinal disorders GASTRITIS	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Infections and infestations DIVERTICULITIS	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Infections and infestations PNEUMONIA	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.81% 1/123 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.9% 1/54 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 2 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 2 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Nervous system disorders SCIATICA	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.81% 1/123 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Renal and urinary disorders URETEROLITHIASIS	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.9% 1/54 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Reproductive system and breast disorders UTERINE POLYP	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).

Other adverse events

Other adverse events
Measure	Part 1: MTX Escalated Dose n=122 participants at risk Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew) (MTX 20 - 25 mg or highest tolerable dose ew)	Part 1: ADA + MTX n=123 participants at risk Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew (ADA 40 mg eow + MTX 15 mg ew	Part 2: MTX Escalated Dose n=15 participants at risk Participants achieving MDA at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose (MTX 20 - 25 mg or highest tolerable dose ew)	Part 2: ADA + MTX Escalated Dose n=95 participants at risk Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew (ADA 40 mg eow plus MTX 20 - 25 mg or highest tolerable dose ew)	Part 2: ADA n=54 participants at risk Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy (ADA 40 mg eow),	Part 2: ADA ew + MTX n=63 participants at risk Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew (ADA 40 mg ew plus MTX 15 mg ew)
Gastrointestinal disorders NAUSEA	9.0% 11/122 • Number of events 13 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	4.1% 5/123 • Number of events 5 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.7% 1/15 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	4.2% 4/95 • Number of events 4 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
General disorders DRUG INTOLERANCE	6.6% 8/122 • Number of events 12 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Hepatobiliary disorders HEPATITIS	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.7% 1/15 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Infections and infestations BRONCHITIS	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.7% 1/15 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Infections and infestations NASOPHARYNGITIS	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.3% 6/95 • Number of events 6 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.9% 1/54 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	3.2% 2/63 • Number of events 2 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Infections and infestations PNEUMONIA	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.7% 1/15 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.0% 11/122 • Number of events 11 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	8.1% 10/123 • Number of events 10 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	13.7% 13/95 • Number of events 13 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	3.7% 2/54 • Number of events 2 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	14.3% 9/63 • Number of events 11 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.7% 1/15 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	2.1% 2/95 • Number of events 4 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.9% 1/54 • Number of events 2 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	4.8% 3/63 • Number of events 5 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Investigations TRANSAMINASES INCREASED	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.7% 1/15 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.6% 1/63 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.1% 1/95 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	1.9% 1/54 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.3% 4/63 • Number of events 4 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Musculoskeletal and connective tissue disorders PSORIATIC ARTHROPATHY	0.00% 0/122 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/123 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.7% 1/15 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	6.3% 4/63 • Number of events 4 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Nervous system disorders HEADACHE	1.6% 2/122 • Number of events 3 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	8.1% 10/123 • Number of events 10 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).
Respiratory, thoracic and mediastinal disorders COUGH	0.82% 1/122 • Number of events 1 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	5.7% 7/123 • Number of events 8 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/15 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/95 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/54 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).	0.00% 0/63 • All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed. The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms). Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively: * Safety analyses during Part 1 (up to Week 16). * Safety analyses during Part 2 (Week 16 to Week 32).

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