Trial Outcomes & Findings for A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (NCT NCT02951533)

Last Updated: 2020-02-28

Results Overview

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

At Week 24

Results posted on

2020-02-28

Participant Flow

Total of 119 participants were enrolled and randomized, 118 (GUS \[60\], FAE \[58 participants\]) were treated in this study. Out of them, 42 participants completed study in Part III.

Participant milestones

Participant milestones
Measure	Guselkumab (GUS) Participants received guselkumab (GUS) 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Participants who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52 (Part IIb). Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Participants who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and followed-up until loss of response/ until Week 100.	Fumaric Acid Esters (FAE) Participants received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6\*120 mg/day) as per local prescribing information up to Week 24 (Part I). Participants who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm switched to 100 mg GUS at Week 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For participants who discontinued study, safety follow-up was done at Week 32 (Part I) / Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.	FAE to Guselkumab At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Weeks 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who received GUS in Study Part II (participants who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Part I (Week 0 Through Week 24) STARTED	60	59	0
Part I (Week 0 Through Week 24) Treated	60	58	0
Part I (Week 0 Through Week 24) COMPLETED	56	36	0
Part I (Week 0 Through Week 24) NOT COMPLETED	4	23	0
Part IIa (Week 24 Through Week 32) STARTED	56	35	0
Part IIa (Week 24 Through Week 32) PASI 75 Responder at Week 32	54	14	0
Part IIa (Week 24 Through Week 32) PASI 75 Non-responder at Week 32	1	20	0
Part IIa (Week 24 Through Week 32) COMPLETED	55	34	0
Part IIa (Week 24 Through Week 32) NOT COMPLETED	1	1	0
Part IIb (Week 32 Through Week 56) STARTED	55	14	20
Part IIb (Week 32 Through Week 56) COMPLETED	54	10	20
Part IIb (Week 32 Through Week 56) NOT COMPLETED	1	4	0
Part III (Week 64 Through Week 100) STARTED	36	0	12
Part III (Week 64 Through Week 100) COMPLETED	32	0	10
Part III (Week 64 Through Week 100) NOT COMPLETED	4	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Guselkumab (GUS) Participants received guselkumab (GUS) 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Participants who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52 (Part IIb). Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Participants who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and followed-up until loss of response/ until Week 100.	Fumaric Acid Esters (FAE) Participants received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6\*120 mg/day) as per local prescribing information up to Week 24 (Part I). Participants who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm switched to 100 mg GUS at Week 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For participants who discontinued study, safety follow-up was done at Week 32 (Part I) / Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.	FAE to Guselkumab At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Weeks 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who received GUS in Study Part II (participants who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Part I (Week 0 Through Week 24) Adverse Event	0	16	0
Part I (Week 0 Through Week 24) Lost to Follow-up	2	2	0
Part I (Week 0 Through Week 24) Withdrawal by Subject	2	4	0
Part I (Week 0 Through Week 24) Noncompliance with Study Drug	0	1	0
Part IIa (Week 24 Through Week 32) Adverse Event	0	1	0
Part IIa (Week 24 Through Week 32) Withdrawal by Subject	1	0	0
Part IIb (Week 32 Through Week 56) Adverse Event	0	2	0
Part IIb (Week 32 Through Week 56) Lost to Follow-up	1	2	0
Part III (Week 64 Through Week 100) Prohibited Medication Therapy	1	0	0
Part III (Week 64 Through Week 100) Lost to Follow-up	1	0	0
Part III (Week 64 Through Week 100) Withdrawal by Subject	2	0	2

Baseline Characteristics

A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guselkumab (GUS) n=60 Participants Participants received guselkumab (GUS) 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Participants who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52 (Part IIb). Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Participants who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and followed-up until loss of response/ until Week 100.	Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6\*120 mg/day) as per local prescribing information up to Week 24 (Part I). Participants who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm switched to 100 mg GUS at Week 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For participants who discontinued study, safety follow-up was done at Week 32 (Part I) / Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.	Total n=119 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 13.98 • n=5 Participants	45.8 years STANDARD_DEVIATION 13.72 • n=7 Participants	42.4 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	42 Participants n=7 Participants	82 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Germany	60 Participants n=5 Participants	59 Participants n=7 Participants	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 24

Population: Efficacy analysis set (EAS) included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using non-responder imputation (NRI) (participants with missing data at Week 4,16 and 24 were considered non-responders).

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24	81.7 Percentage of Participants	13.6 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24	90.0 Percentage of Participants	27.1 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24	61.7 Percentage of Participants	16.9 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24	31.7 Percentage of Participants	3.4 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: EAS included all participants who were randomized to one of two treatment groups (GUS or FAE) at Week 0 regardless of treatment they received. Missing data was imputed using last observed carried forward (LOCF) imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).

The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (\>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score=average value\*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=58 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24 Symptom score	-52.0 Units on a scale Standard Deviation 22.0	-34.0 Units on a scale Standard Deviation 25.4
Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24 Sign score	-59.8 Units on a scale Standard Deviation 18.3	-39.7 Units on a scale Standard Deviation 26.7

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

The PSSD (7 day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=58 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24 Itch score	-5.85 Units on a scale Standard Deviation 2.83	-3.90 Units on a scale Standard Deviation 2.86
Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24 Pain score	-5.07 Units on a scale Standard Deviation 2.86	-2.93 Units on a scale Standard Deviation 3.12
Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24 Scaling score	-6.48 Units on a scale Standard Deviation 2.25	-4.43 Units on a scale Standard Deviation 3.02

SECONDARY outcome

Timeframe: At Week 24

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. Percentage of Participants who Achieved an absolute PASI score less than or equal to (=\<) 1 were assessed.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24	66.7 Percentage of Participants	10.2 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24	51.7 Percentage of Participants	6.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using LOCF imputation method. Here "N" (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=59 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=57 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24	-18.5 Change in BSA (% points) Standard Deviation 10.4	-9.2 Change in BSA (% points) Standard Deviation 11.2

SECONDARY outcome

Timeframe: Baseline and Week 24

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=58 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Change From Baseline in DLQI Score at Week 24	-15.2 Units on a scale Standard Deviation 5.1	-9.4 Units on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: At Week 24

Population: EAS: participants randomized to one of two treatments (GUS or FAE) at Week 0 regardless of treatment received and SP, ss-IGA Score\>=2 at Baseline. Missing data was imputed using NRI (participants with missing data at Week 4,16, 24 were non-responders).

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=53 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24	48.1 Percentage of Participants	13.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF. Here "N" (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=59 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=57 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24 SF-36 MCS scores	5.8 Units on a scale Standard Deviation 10.6	6.5 Units on a scale Standard Deviation 9.3
Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24 SF-36 PCS scores	8.0 Units on a scale Standard Deviation 6.9	2.3 Units on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40, 48, and 56 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=14 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56	98.1 Percentage of Participants	64.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 56

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=14 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56	85.2 Percentage of Participants	35.7 Percentage of Participants

SECONDARY outcome

Timeframe: Week 56

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=14 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56	64.8 Percentage of Participants	21.4 Percentage of Participants

SECONDARY outcome

Timeframe: Week 56

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=14 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With a PASI 75 Response at Week 56	98.1 Percentage of Participants	64.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 56

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=14 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With a PASI 90 Response at Week 56	90.7 Percentage of Participants	50.0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 56

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=14 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With a PASI 100 Response at Week 56	53.7 Percentage of Participants	21.4 Percentage of Participants

SECONDARY outcome

Timeframe: Week 56

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=54 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=14 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56	72.2 Percentage of Participants	28.6 Percentage of Participants

SECONDARY outcome

Timeframe: Week 32

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this outcome measure (OM).

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32	90.0 Percentage of Participants	23.7 Percentage of Participants

SECONDARY outcome

Timeframe: Week 32

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32	78.3 Percentage of Participants	11.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 32

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32	43.3 Percentage of Participants	6.8 Percentage of Participants

SECONDARY outcome

Timeframe: Week 32

DLQI is 10-item questionnaire that measures impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on participant's life; 2-6 =small effect on participant's life; 7-12 = moderate effect on participant's life; 13-18 =very large effect on participant's life; 19-30 =extremely large effect on participant's life. Higher score indicates low quality of life due to more severe disease. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=59 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32	63.3 Percentage of Participants	16.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 100

Population: Study Part III analysis set included all participants who were treated with GUS during Part IIb (Weeks 32 to 64 of Study, and who were withdrawn from study treatment) and entered Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were non-responders).

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal	47.2 Percentage of Participants	25.0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.

The time to loss of response from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100	315 Days Interval 301.0 to The upper bound of the 95 percent confidence interval (CI) for median was not reached due to insufficient event rate.	293 Days Interval 219.0 to 315.0

SECONDARY outcome

Timeframe: Week 100

The time to PASI\>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100	306 Days Interval 227.0 to 308.0	226 Days Interval 141.0 to 308.0

SECONDARY outcome

Timeframe: Week 100

The time to loss of response from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100	336 Days Interval 322.0 to The upper bound of the 95 percent confidence interval (CI) for median was not reached due to insufficient event rate.	321 Days Interval 251.0 to 350.0

SECONDARY outcome

Timeframe: Week 100

The time to PASI\>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100	334 Days Interval 252.0 to 337.0	254 Days Interval 173.0 to 329.0

SECONDARY outcome

Timeframe: Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal	13.9 Percentage of Participants	8.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 100

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100	5.6 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100 PASI Score <=2	19.4 Percentage of Participants	8.3 Percentage of Participants
Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100 PASI Score <=3	30.6 Percentage of Participants	16.7 Percentage of Participants
Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100 PASI Score <=5	47.2 Percentage of Participants	25.0 Percentage of Participants
Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100 PASI Score <=1	8.3 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Week 56) and Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100 Symptom Score at Baseline (Week 56)	3.4 Units on a scale Standard Deviation 5.4	11.2 Units on a scale Standard Deviation 13.2
Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100 Change in Symptom score at Week 100	25.1 Units on a scale Standard Deviation 24.7	30.7 Units on a scale Standard Deviation 21.7
Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100 Sign Score at Baseline (Week 56)	5.4 Units on a scale Standard Deviation 9.3	13.5 Units on a scale Standard Deviation 12.9
Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100 Change in Sign score at Week 100	29.4 Units on a scale Standard Deviation 24.8	37.9 Units on a scale Standard Deviation 28.7

SECONDARY outcome

Timeframe: Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100	8.3 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100	30.6 Percentage of participants	16.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 56) and Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100 Baseline (Week 56)	0.9 Change in BSA (% points) Standard Deviation 1.2	1.5 Change in BSA (% points) Standard Deviation 2.1
Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100 Change at Week 100	6.1 Change in BSA (% points) Standard Deviation 6.3	9.1 Change in BSA (% points) Standard Deviation 5.8

SECONDARY outcome

Timeframe: Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100	25 Percentage of participants	8.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 56) and Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Change From Baseline in DLQI Score at Week 100 Baseline (Week 56)	0.9 Units on a scale Standard Deviation 1.3	3.5 Units on a scale Standard Deviation 4.0
Part III: Change From Baseline in DLQI Score at Week 100 Change at Week 100	5.3 Units on a scale Standard Deviation 6.0	8.0 Units on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: Week 100

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100	25 Percentage of participants	8.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 100

Population: Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64, 76, 88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp psoriasis and ss-IGA score \>=2 at Baseline (Week 0).

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=34 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0)	14.7 Percentage of participants	8.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 100

Population: Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp Psoriasis and an ss-IGA Score \>=2 (at least mild disease) at Baseline (Week 0).

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=34 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0)	32.4 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 56) and Week 100

Population: Part III analysis set included all participants treated with GUS during Part IIb (Weeks 32 to 64, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF method.

SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0 = worst HRQL, 100=best HRQL. Higher scores indicate better health status.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100 SF-36 PCS scores: Baseline (Week 56)	57.8 Units on a scale Standard Deviation 3.0	54.9 Units on a scale Standard Deviation 5.5
Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100 SF-36 PCS scores: Change at Week 100	-4.3 Units on a scale Standard Deviation 6.7	-3.7 Units on a scale Standard Deviation 7.0
Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100 SF-36 MCS scores: Change at Week 100	-2.8 Units on a scale Standard Deviation 5.9	-3.1 Units on a scale Standard Deviation 5.9
Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100 SF-36 MCS scores: Baseline (Week 56)	53.4 Units on a scale Standard Deviation 6.2	44.2 Units on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: Up to Week 32

Population: Safety analysis set included all participants randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 and received at least 1 dose of study drug as per actual treatment received during study irrespective of treatment assigned at randomization. Here N (number of subjects analyzed) signifies number of participants evaluable for this OM.

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=60 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=58 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability	78.3 Percentage of Participants	98.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 32 to Week 64

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Here, n (number of participants analyzed) signifies number of participants analyzed for this OM for specified category.

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=55 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=34 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability PASI75 Responders	79.6 Percentage of Participants	92.9 Percentage of Participants
Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability PASI75 Non-responders	0 Percentage of Participants	70.0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 64 to Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study) and entered Study Part III.

ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64.

Outcome measures

Outcome measures
Measure	Part I: Guselkumab (GUS) n=36 Participants Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.	Part I: Fumaric Acid Esters (FAE) n=12 Participants Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability	5.6 Percentage of Participants	0 Percentage of Participants

Adverse Events

Part I/IIa (Week 0 to Week 32): Guselkumab (GUS)

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE)

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Part IIb (Week 32 Through Week 56): Guselkumab (GUS)

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Part IIb (Week 32 Through Week 56): FAE to Guselkumab

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Part III (Week 64 Through Week 100): Guselkumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part III (Week 64 Through Week 100): FAE to Guselkumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part I/IIa (Week 0 to Week 32): Guselkumab (GUS) n=60 participants at risk In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.	Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) n=58 participants at risk In Part I, Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.	Part IIb (Week 32 Through Week 56): Guselkumab (GUS) n=55 participants at risk At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of guselkumab arm continued to receive guselkumab 100 mg SC every 8 weeks (weeks 36, 44 and 52). Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.	Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE) n=14 participants at risk At Week 32, PASI 75 response was evaluated and PASI 75 responders of the FAE arm continued to receive commercially available FAE tablets specifically labeled for the study during Part IIb up to Week 56. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.	Part IIb (Week 32 Through Week 56): FAE to Guselkumab n=20 participants at risk At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to 100 mg guselkumab SC at Weeks 32 and continued at Week 36, 44 and Week 52. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.	Part III (Week 64 Through Week 100): Guselkumab n=36 participants at risk Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.	Part III (Week 64 Through Week 100): FAE to Guselkumab n=12 participants at risk At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Blood and lymphatic system disorders Thymus Enlargement	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Inguinal Hernia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Immune system disorders Sarcoidosis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Hydronephrosis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Cardiac disorders Myocardial Infarction	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Tonsillitis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.

Other adverse events

Other adverse events
Measure	Part I/IIa (Week 0 to Week 32): Guselkumab (GUS) n=60 participants at risk In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.	Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) n=58 participants at risk In Part I, Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6\*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.	Part IIb (Week 32 Through Week 56): Guselkumab (GUS) n=55 participants at risk At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of guselkumab arm continued to receive guselkumab 100 mg SC every 8 weeks (weeks 36, 44 and 52). Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.	Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE) n=14 participants at risk At Week 32, PASI 75 response was evaluated and PASI 75 responders of the FAE arm continued to receive commercially available FAE tablets specifically labeled for the study during Part IIb up to Week 56. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.	Part IIb (Week 32 Through Week 56): FAE to Guselkumab n=20 participants at risk At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to 100 mg guselkumab SC at Weeks 32 and continued at Week 36, 44 and Week 52. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.	Part III (Week 64 Through Week 100): Guselkumab n=36 participants at risk Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.	Part III (Week 64 Through Week 100): FAE to Guselkumab n=12 participants at risk At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Blood and lymphatic system disorders Anaemia	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Blood and lymphatic system disorders Eosinophilia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	8.6% 5/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	36.2% 21/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	35.7% 5/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Blood and lymphatic system disorders Monocytosis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Ear and labyrinth disorders Ear Pain	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Ear and labyrinth disorders Middle Ear Inflammation	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Ear and labyrinth disorders Tympanic Membrane Perforation	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Ear and labyrinth disorders Vertigo	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Eye disorders Dry Eye	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Eye disorders Visual Acuity Reduced	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Eye disorders Visual Impairment	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.2% 3/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Abdominal Distension	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Abdominal Pain	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	15.5% 9/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Abdominal Pain Upper	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	31.0% 18/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Constipation	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Defaecation Urgency	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Diarrhoea	11.7% 7/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	58.6% 34/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Dry Mouth	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Dyspepsia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Enteritis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Faeces Soft	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Flatulence	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Gastritis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Gastrointestinal Disorder	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Gastrointestinal Pain	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Haematochezia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Nausea	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	10.3% 6/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Tooth Disorder	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Toothache	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Gastrointestinal disorders Vomiting	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Chest Pain	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Chills	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Fatigue	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	8.6% 5/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Feeling Hot	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Inflammation	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Injection Site Rash	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Malaise	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Oedema Peripheral	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Pyrexia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Hepatobiliary disorders Hyperbilirubinaemia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Immune system disorders Seasonal Allergy	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Bronchitis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	9.1% 5/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Conjunctivitis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Cystitis	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Ear Infection	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Folliculitis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Gastroenteritis	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Gastrointestinal Infection	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Herpes Zoster	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Influenza	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Nasopharyngitis	41.7% 25/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	32.8% 19/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	50.9% 28/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	57.1% 8/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	40.0% 8/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Onychomycosis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Oral Herpes	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Otitis Media	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Pharyngitis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Rhinitis	8.3% 5/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Sinusitis	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Skin Candida	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Tinea Pedis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Tonsillitis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Urinary Tract Infection	5.0% 3/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Viral Infection	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Bone Contusion	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Laceration	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Ligament Sprain	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Post Procedural Haematoma	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Post-Traumatic Neck Syndrome	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Sunburn	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Traumatic Haematoma	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Alanine Aminotransferase Increased	6.7% 4/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.2% 3/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.5% 3/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Aspartate Aminotransferase Increased	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	2.8% 1/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Blood Glucose Increased	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Gamma-Glutamyltransferase Increased	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.2% 3/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Hepatic Enzyme Increased	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Human Chorionic Gonadotropin Increased	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Lymph Node Palpable	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Transaminases Increased	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Weight Decreased	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Weight Increased	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Metabolism and nutrition disorders Food Intolerance	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Metabolism and nutrition disorders Hypercholesterolaemia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Metabolism and nutrition disorders Hyperuricaemia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 4/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.2% 3/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Articular Calcification	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Back Pain	5.0% 3/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.5% 3/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Muscle Tightness	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Myalgia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.0% 3/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Pain in Extremity	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Tendonitis	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Giant Cell Tumour of Tendon Sheath	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Carpal Tunnel Syndrome	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Dizziness	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Dysaesthesia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Headache	15.0% 9/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	13.8% 8/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.5% 3/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Paraesthesia	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Transient Ischaemic Attack	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Product Issues Device Breakage	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Psychiatric disorders Mood Altered	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Psychiatric disorders Restlessness	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Glycosuria	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Haematuria	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Leukocyturia	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Proteinuria	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Renal Failure	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Ureterolithiasis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.5% 3/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Respiratory, thoracic and mediastinal disorders Pharyngeal Erythema	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary Arterial Hypertension	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	10.0% 2/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Respiratory, thoracic and mediastinal disorders Throat Irritation	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Dermatitis Contact	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Hyperkeratosis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Neurodermatitis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Polymorphic Light Eruption	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Prurigo	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Pruritus	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	8.6% 5/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Psoriasis	3.3% 2/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	10.3% 6/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Rash Erythematous	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Rosacea	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.2% 3/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Skin Burning Sensation	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Surgical and medical procedures Dental Operation	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Surgical and medical procedures Skin Neoplasm Excision	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Vascular disorders Aortic Elongation	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Vascular disorders Flushing	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	32.8% 19/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Vascular disorders Hypertension	6.7% 4/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Vascular disorders Lymphoedema	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Blood and lymphatic system disorders Leukopenia	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.4% 2/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Cardiac disorders Bradycardia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Ear and labyrinth disorders Deafness	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Endocrine disorders Hypothyroidism	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Eye disorders Eye Haemorrhage	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
General disorders Hypothermia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Bronchitis Viral	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Furuncle	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Gastroenteritis Norovirus	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Gastroenteritis Salmonella	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Impetigo	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Periodontitis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Pulpitis Dental	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Pyelonephritis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	14.3% 2/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Root Canal Infection	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Rotavirus Infection	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Infections and infestations Tooth Infection	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	2.8% 1/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Contusion	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Limb Injury	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Injury, poisoning and procedural complications Wound	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Blood Glucose Decreased	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Breath Sounds Abnormal	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Lymphocyte Count Increased	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Lymphocyte Morphology Abnormal	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations Protein Urine Present	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Investigations White Blood Cells Urine Positive	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Arthritis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Bursitis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Femoroacetabular Impingement	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Osteochondrosis	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Musculoskeletal and connective tissue disorders Spinal Pain	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic Naevus	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	3.6% 2/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Cervicogenic Vertigo	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Hypoaesthesia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Nervous system disorders Migraine	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	7.1% 1/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Psychiatric disorders Insomnia	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Renal and urinary disorders Ketonuria	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.7% 1/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	5.0% 1/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Acne	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Alopecia	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Skin and subcutaneous tissue disorders Urticaria	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Vascular disorders Hypotension	1.7% 1/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Vascular disorders Peripheral Venous Disease	0.00% 0/60 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/58 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	1.8% 1/55 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/14 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/20 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/36 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.	0.00% 0/12 • Up to Week 100 Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.

Additional Information

Senior Director

Janssen-Cilag GmbH

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER